- No Title 1572546679
- No Title 1572547361
- No Title 1572548802
- No Title 1572550617
- No Title 1572550823
- No Title 1572550889
- No Title 1572551658
- No Title 1572551971
- No Title 1572553531
- No Title 1572553660
- No Title 1572553661
- No Title 1572554205
- No Title 1572554206
- No Title 1572554946
- No Title 1572449238
- Warning
- Principal Display Panel - 300 Mg/15 Mg Bottle Label
- Principal Display Panel - 300 Mg/30 Mg Bottle Label
- Principal Display Panel - 300 Mg/60 Mg Bottle Label
- No Title 1572449340
- No Title 1572449341
- Principal Display Panel - 300 Mg/15 Mg
- No Title 1572448090
- Description
- Clinical Pharmacology
- Indications And Usage
- Contraindications
- Warnings
- Precautions
- Adverse Reactions
- Drug Abuse And Dependence
- Overdosage
- Dosage And Administration
- How Supplied
- This Is An Image Of The Label For 300 Mg/30 Mg Acetaminophen And Codeine Phosphate Tablets.
- No Title 1572449615
- No Title 1572449616
- Principal Display Panel
- No Title 1572450115
- No Title 1572450396
- Description
- Storage And Handling
- Package/label Display Panel - 300mg/ 30mg 20s
- No Title 1572451860
- Principal Display Panel - 300 Mg/60 Mg
- No Title 1572452292
- Acetaminophen And Codeine Phosphate Tablets, Usp300 Mg/30 Mg
- No Title 1572453226
- No Title 1572457195
- Repackaging Information
- Principal Display Panel - 30/300mg
- Principal Display Panel - 60/300mg
- No Title 1572457503
- No Title 1572457547
No Title 1572546679 ⮝
Manufactured for:
QUALITEST PHARMACEUTICALS
Huntsville, AL 358118182436
copy of label
R11/07-R2
ACETAMINOPHEN AND CODEINE
acetaminophen and codeine phosphate tablet
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:67296-0544(NDC:0603-2338) Route of Administration ORAL DEA Schedule CIII
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 300 mg CODEINE PHOSPHATE (UNII: GSL05Y1MN6) (CODEINE - UNII:Q830PW7520) CODEINE PHOSPHATE 30 mg
Inactive Ingredients Ingredient Name Strength MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POVIDONE (UNII: FZ989GH94E) STARCH, CORN (UNII: O8232NY3SJ) SODIUM METABISULFITE (UNII: 4VON5FNS3C) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) STEARIC ACID (UNII: 4ELV7Z65AP)
Product Characteristics Color white Score 2 pieces Shape ROUND Size 10mm Flavor Imprint Code 2064;V;3 Contains
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:67296-0544-1 15 in 1 BOTTLE 2 NDC:67296-0544-2 30 in 1 BOTTLE 3 NDC:67296-0544-3 20 in 1 BOTTLE
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA089805 09/30/1988
Labeler - RedPharm Drug Inc. (008039641)
Establishment Name Address ID/FEI Business Operations Vintage Pharmaceuticals, LLC 825839835 manufacture Revised: 5/2011 Document Id: 980307ab-36fe-453a-b5e4-eaf528919dd1 Set id: 65921b50-5215-41cc-91b9-ac5ea6282bb1 Version: 8 Effective Time: 20110524 RedPharm Drug Inc.
No Title 1572547361 ⮝
Manufactured for:
QUALITEST PHARMACEUTICALS
Huntsville, AL 358118182436
R11/07-R2
No Title 1572548802 ⮝
BOXED WARNING
Hepatotoxicity:
Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed 4000 milligrams per day, and often involve more than one acetaminophen-containing product.
WARNING:
Death Related to Ultra-Rapid Metabolism of Codeine to Morphine Respiratory depression and death have occurred in children who received codeine following tonsillectomy and/or adenoidectomy and had evidence of being ultra-rapid metabolizers of codeine due to a CYP2D6 polymorphism.
No Title 1572550617 ⮝
Medication Guide
Acetaminophen and Codeine Phosphate Tablets (a seet' a min' oh fen and koe' deen fos' fate), CIII
Acetaminophen and Codeine Phosphate Tablets are:
- A strong prescription pain medicine that contains an opioid (narcotic) that is used to manage mild to moderate pain, when other pain treatments such as non-opioid pain medicines do not treat your pain well enough or you cannot tolerate them.
- An opioid pain medicine that can put you at risk for overdose and death. Even if you take your dose correctly as prescribed, you are at risk for opioid addiction, abuse, and misuse that can lead to death.
Important information about Acetaminophen and Codeine Phosphate Tablets:
- Get emergency help right away if you take too much acetaminophen and codeine phosphate tablets (overdose). When you first start taking acetaminophen and codeine tablets, when your dose is changed, or if you take too much (overdose), serious or life-threatening breathing problems that can lead to death may occur.
- Taking acetaminophen and codeine tablets with other opioid medicines, benzodiazepines, alcohol, or other central nervous system depressants (including street drugs) can cause severe drowsiness, decreased awareness, breathing problems coma and death
- Never give anyone else your acetaminophen and codeine phosphate tablets. They could die from taking it. Selling or giving away acetaminophen and codeine phosphate tablets are against the law.
- Store acetaminophen and codeine phosphate tablets securely, out of sight and reach of children, and in a location not accessible by others, including visitors to the home.
Important Information Guiding Use in Pediatric Patients:
- Do not give acetaminophen and codeine phosphate tablets to a child younger than 12 years of age.
- Do not give acetaminophen and codeine phosphate tablets to a child younger than 18 years of age after surgery to remove the tonsils and/or adenoids.
- Avoid giving acetaminophen and codeine phosphate tablets to children between 12 to 18 years of age who have risk factors for breathing problems such as obstructive sleep apnea, obesity, or underlying lung problems.
Do not take Acetaminophen and Codeine Phosphate Tablets if you have:
- severe asthma, trouble breathing, or other lung problems.
- a bowel blockage or narrowing of the stomach or intestines.
- previously had an allergic reaction to codeine or acetaminophen.
Before taking Acetaminophen and Codeine Phosphate Tablets, tell your healthcare provider if you have a history of:
- head injury, seizures
- liver, kidney, thyroid problems
- problems urinating
- pancreas or gallbladder problems
- abuse of street or prescription drugs, alcohol addiction, or mental health problems.
- Have been told by your healthcare provider that you are a rapid metabolizer of certain medicines.
Tell your healthcare provider if you are:
- pregnant or planning to become pregnant. Prolonged use of acetaminophen and codeine phosphate tablets during pregnancy can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated.
- breastfeeding. Not recommended; may harm your baby.
- taking prescription or over-the-counter medicines, vitamins, or herbal supplements. Acetaminophen and codeine phosphate tablets with certain other medicines can cause serious side effects that could lead to death.
When taking Acetaminophen and Codeine Phosphate Tablets:
- Do not change your dose. Take acetaminophen and codeine phosphate tablets exactly as prescribed by your healthcare provider. Use the lowest dose possible for the shortest time needed.
- Take your prescribed dose every 4 hours as needed. Do not take more than your prescribed dose. If you miss a dose, take your next dose when needed.
- Call your healthcare provider if the dose you are taking does not control your pain.
- If you have been taking acetaminophen and codeine phosphate tablets regularly, do not stop taking acetaminophen and codeine phosphate tablets without talking to your healthcare provider.
- Dispose of expired, unwanted, or unused acetaminophen and codeine phosphate tablets by taking your drug to an authorized DEA-registered collector or drug take-back program. If one is not available, you can dispose of acetaminophen and codeine phosphate tablets by mixing the product with dirt, cat litter, or coffee grounds; placing the mixture in a sealed plastic bag, and throwing the bag in your trash.
While taking Acetaminophen and Codeine Phosphate Tablets DO NOT:
- Drive or operate heavy machinery, until you know how acetaminophen and codeine tablets affect you. Acetaminophen and codeine phosphate tablets can make you sleepy, dizzy, or lightheaded.
- Drink alcohol or use prescription or over-the-counter medicines that contain alcohol. Using products containing alcohol during treatment with acetaminophen and codeine phosphate tablets may cause you to overdose and die.
The possible side effects of Acetaminophen and Codeine Tablets :
- constipation, nausea, sleepiness, vomiting, tiredness, headache, dizziness, abdominal pain. Call your healthcare provider if you have any of these symptoms and they are severe.
Get emergency medical help if you have:
- trouble breathing, shortness of breath, fast heartbeat, chest pain, swelling of your face, tongue, or throat, extreme drowsiness, light-headedness when changing positions, feeling faint, agitation, high body temperature, trouble walking, stiff muscles, or mental changes such as confusion.
These are not all the possible side effects of acetaminophen and codeine phosphate tablets. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. For more information go to dailymed.nlm.nih.gov.
Distributed by: Par Pharmaceutical, Chestnut Ridge, NY 10977 1-800-828-9393
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Issued: May 2019 PD2338H-01-1-01
No Title 1572550823 ⮝
Manufactured for:
QUALITEST PHARMACEUTICALS
Huntsville, AL 358118182436
Rev 10/13
R8
No Title 1572550889 ⮝
Manufactured for:
QUALITEST PHARMACEUTICALS
Huntsville, AL 35811Repackaged By:
Aidarex Pharmaceuticals, LLC.
Corona, CA 928808182436
R6/11-R5
No Title 1572551658 ⮝
CIII
Rx only
No Title 1572551971 ⮝
Manufactured for:
QUALITEST PHARMACEUTICALS
Huntsville, AL 35811Repackaged By:
Aidarex Pharmaceuticals, LLC.
Corona, CA 928808182436
Rev 10/13
R8
No Title 1572553531 ⮝
Medication Guide
Acetaminophen and Codeine Phosphate Tablets (a seet a min oh fen and koe deen fos fate)
CIIIAcetaminophen and Codeine Phosphate Tablets are:
- A strong prescription pain medicine that contains an opioid (narcotic) that is used to manage mild to moderate pain, when other pain treatments such as non-opioid pain medicines do not treat your pain well enough or you cannot tolerate them.
- An opioid pain medicine that can put you at risk for overdose and death. Even if you take your dose correctly as prescribed, you are at risk for opioid addiction, abuse, and misuse that can lead to death.
Important information about Acetaminophen and Codeine Phosphate Tablets:
- Get emergency help right away if you take too much Acetaminophen and Codeine Phosphate tablets (overdose). When you first start taking acetaminophen and codeine tablets, when your dose is changed, or if you take too much (overdose), serious or life-threatening breathing problems that can lead to death may occur.
- Taking acetaminophen and codeine tablets with other opioid medicines, benzodiazepines, alcohol, or other central nervous system depressants (including street drugs) can cause severe drowsiness, decreased awareness, breathing problems, coma, and death
- Never give anyone else your acetaminophen and codeine phosphate tablets. They could die from taking it. Selling or giving away acetaminophen and codeine phosphate tablets is against the law.
- Store acetaminophen and codeine phosphate tablets securely, out of sight and reach of children, and in a location not accessible by others, including visitors to the home.
Important Information Guiding Use in Pediatric Patients:
- Do not give acetaminophen and codeine phosphate tablets to a child younger than 12 years of age.
- Do not give acetaminophen and codeine phosphate tablets to a child younger than 18 years of age after surgery to remove the tonsils and/or adenoids.
- Avoid giving acetaminophen and codeine phosphate tablets to children between 12 to 18 years of age who have risk factors for breathing problems such as obstructive sleep apnea, obesity, or underlying lung problems.
Do not take Acetaminophen and Codeine Phosphate Tablets if you have:
- severe asthma, trouble breathing, or other lung problems.
- a bowel blockage or narrowing of the stomach or intestines.
- previously had an allergic reaction to codeine or acetaminophen.
Before taking Acetaminophen and Codeine Phosphate Tablets, tell your healthcare provider if you have a history of:
- head injury, seizures
- liver, kidney, thyroid problems
- problems urinating
- pancreas or gallbladder problems
- abuse of street or prescription drugs, alcohol addiction, or mental health problems
- Have been told by your healthcare provider that you are a rapid metabolizer of certain medicines
Tell your healthcare provider if you are:
- pregnant or planning to become pregnant. Prolonged use of acetaminophen and codeine phosphate tablets during pregnancy can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated.
- breastfeeding. Not recommended; may harm your baby.
- taking prescription or over-the-counter medicines, vitamins, or herbal supplements. Acetaminophen and codeine phosphate tablets with certain other medicines can cause serious side effects that could lead to death.
When taking Acetaminophen and Codeine Phosphate Tablets:
- Do not change your dose. Take acetaminophen and codeine phosphate tablets exactly as prescribed by your healthcare provider. Use the lowest dose possible for the shortest time needed.
- Take your prescribed dose every 4 hours as needed. Do not take more than your prescribed dose. If you miss a dose, take your next dose when needed.
- Call your healthcare provider if the dose you are taking does not control your pain.
- If you have been taking acetaminophen and codeine phosphate tablets regularly, do not stop taking acetaminophen and codeine phosphate tablets without talking to your healthcare provider.
- Dispose of expired, unwanted, or unused acetaminophen and codeine phosphate tablets by taking your drug to an authorized DEA-registered collector or drug take-back program. If one is not available, you can dispose of acetaminophen and codeine phosphate tablets by mixing the product with dirt, cat litter, or coffee grounds; placing the mixture in a sealed plastic bag, and throwing the bag in your trash.
While taking Acetaminophen and Codeine Phosphate Tablets DO NOT:
- Drive or operate heavy machinery, until you know how acetaminophen and codeine tablets affect you. Acetaminophen and codeine phosphate tablets can make you sleepy, dizzy, or lightheaded.
- Drink alcohol or use prescription or over-the-counter medicines that contain alcohol. Using products containing alcohol during treatment with acetaminophen and codeine phosphate tablets may cause you to overdose and die.
The possible side effects of Acetaminophen and Codeine Tablets:
- constipation, nausea, sleepiness, vomiting, tiredness, headache, dizziness, abdominal pain. Call your healthcare provider if you have any of these symptoms and they are severe.
Get emergency medical help if you have:
- trouble breathing, shortness of breath, fast heartbeat, chest pain, swelling of your face, tongue, or throat, extreme drowsiness, light-headedness when changing positions, feeling faint, agitation, high body temperature, trouble walking, stiff muscles, or mental changes such as confusion.
These are not all the possible side effects of acetaminophen and codeine phosphate tablets. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. For more information go to dailymed.nlm.nih.gov.
Distributed by: Par Pharmaceutical, Chestnut Ridge, NY 10977 1-800-828-9393
This Medication Guide has been approved by the U.S. Food and Drug Administration. Issued: April 2019 OS2337H-01-1-03
No Title 1572553660 ⮝
CIII
Rx only
No Title 1572553661 ⮝
Manufactured for:
QUALITEST PHARMACEUTICALS
Huntsville, AL 35811This Product was Repackaged By Sandhills Packaging For:
Keltman Pharmaceuticals Inc.
1 Lakeland Square, Suite A
Flowood, MS 39232
United States
No Title 1572554205 ⮝
BOXED WARNING
Hepatotoxicity:
Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed 4000 milligrams per day, and often involve more than one acetaminophen-containing product.
WARNING:
Death Related to Ultra-Rapid Metabolism of Codeine to Morphine Respiratory depression and death have occurred in children who received codeine following tonsillectomy and/or adenoidectomy and had evidence of being ultra-rapid metabolizers of codeine due to a CYP2D6 polymorphism.
No Title 1572554206 ⮝
Manufactured for:
QUALITEST PHARMACEUTICALS
Huntsville, AL 358118182436
R2/13-R6
No Title 1572554946 ⮝
Manufactured by:
MUTUAL PHARMACEUTICAL COMPANY, INC.
Philadelphia, PA 19124 USARev 05, October 2013
No Title 1572449238 ⮝
Rx only
Warning ⮝
Hepatotoxicity
Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed 4000 milligrams per day, and often involve more than one acetaminophen-containing product.
WARNING: Death Related to Ultra-Rapid Metabolism of Codeine to Morphine
Respiratory depression and death have occurred in children who received codeine following tonsillectomy and/or adenoidectomy and had evidence of being ultra-rapid metabolizers of codeine due to a CYP2D6 polymorphism.
Principal Display Panel - 300 Mg/15 Mg Bottle Label ⮝
MP
NDC 53489-159-01
ACETAMINOPHEN
AND CODEINE
PHOSPHATE
TABLETS USPCIII
300 mg/
15 mg100 TABLETS
Rx onlyMUTUAL PHARMACEUTICAL CO., INC.
PHILADELPHIA, PA 19124 USA
Principal Display Panel - 300 Mg/30 Mg Bottle Label ⮝
MP
NDC 53489-160-01
ACETAMINOPHEN
AND CODEINE
PHOSPHATE
TABLETS USPCIII
300 mg/
30 mg100 TABLETS
Rx onlyMUTUAL PHARMACEUTICAL CO., INC.
PHILADELPHIA, PA 19124 USA
Principal Display Panel - 300 Mg/60 Mg Bottle Label ⮝
MP
NDC 53489-161-01
ACETAMINOPHEN
AND CODEINE
PHOSPHATE
TABLETS USPCIII
300 mg/
60 mg100 TABLETS
Rx onlyMUTUAL PHARMACEUTICAL CO., INC.
PHILADELPHIA, PA 19124 USA
ACETAMINOPHEN AND CODEINE
acetaminophen and codeine phosphate tablet
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:53489-159 Route of Administration ORAL DEA Schedule CIII
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D) Acetaminophen 300 mg Codeine Phosphate (UNII: GSL05Y1MN6) (Codeine Anhydrous - UNII:UX6OWY2V7J) Codeine Phosphate 15 mg
Inactive Ingredients Ingredient Name Strength starch, corn (UNII: O8232NY3SJ) croscarmellose sodium (UNII: M28OL1HH48) magnesium stearate (UNII: 70097M6I30) cellulose, microcrystalline (UNII: OP1R32D61U) Povidone K90 (UNII: RDH86HJV5Z) sodium lauryl sulfate (UNII: 368GB5141J) stearic acid (UNII: 4ELV7Z65AP)
Product Characteristics Color WHITE Score no score Shape ROUND Size 10mm Flavor Imprint Code MP;111;2 Contains
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53489-159-02 50 in 1 BOTTLE, PLASTIC 2 NDC:53489-159-01 100 in 1 BOTTLE, PLASTIC 3 NDC:53489-159-05 500 in 1 BOTTLE, PLASTIC 4 NDC:53489-159-10 1000 in 1 BOTTLE, PLASTIC
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA089671 02/10/1988
ACETAMINOPHEN AND CODEINE
acetaminophen and codeine phosphate tablet
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:53489-160 Route of Administration ORAL DEA Schedule CIII
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D) Acetaminophen 300 mg Codeine Phosphate (UNII: GSL05Y1MN6) (Codeine Anhydrous - UNII:UX6OWY2V7J) Codeine Phosphate 30 mg
Inactive Ingredients Ingredient Name Strength starch, corn (UNII: O8232NY3SJ) croscarmellose sodium (UNII: M28OL1HH48) magnesium stearate (UNII: 70097M6I30) cellulose, microcrystalline (UNII: OP1R32D61U) Povidone K90 (UNII: RDH86HJV5Z) sodium lauryl sulfate (UNII: 368GB5141J) stearic acid (UNII: 4ELV7Z65AP)
Product Characteristics Color WHITE Score no score Shape ROUND Size 10mm Flavor Imprint Code MP;122;3 Contains
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53489-160-02 50 in 1 BOTTLE, PLASTIC 2 NDC:53489-160-01 100 in 1 BOTTLE, PLASTIC 3 NDC:53489-160-05 500 in 1 BOTTLE, PLASTIC 4 NDC:53489-160-10 1000 in 1 BOTTLE, PLASTIC
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA089672 02/10/1988
ACETAMINOPHEN AND CODEINE
acetaminophen and codeine phosphate tablet
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:53489-161 Route of Administration ORAL DEA Schedule CIII
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D) Acetaminophen 300 mg Codeine Phosphate (UNII: GSL05Y1MN6) (Codeine Anhydrous - UNII:UX6OWY2V7J) Codeine Phosphate 60 mg
Inactive Ingredients Ingredient Name Strength starch, corn (UNII: O8232NY3SJ) croscarmellose sodium (UNII: M28OL1HH48) magnesium stearate (UNII: 70097M6I30) cellulose, microcrystalline (UNII: OP1R32D61U) Povidone K90 (UNII: RDH86HJV5Z) sodium lauryl sulfate (UNII: 368GB5141J) stearic acid (UNII: 4ELV7Z65AP)
Product Characteristics Color WHITE Score no score Shape ROUND Size 10mm Flavor Imprint Code MP;127;4 Contains
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53489-161-02 50 in 1 BOTTLE, PLASTIC 2 NDC:53489-161-01 100 in 1 BOTTLE, PLASTIC 3 NDC:53489-161-05 500 in 1 BOTTLE, PLASTIC 4 NDC:53489-161-10 1000 in 1 BOTTLE, PLASTIC
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA089673 02/10/1988
Labeler - Mutual Pharmaceutical Company, Inc. (121735955) Revised: 10/2013 Document Id: 57ee1a9a-25d6-41ea-b86c-b9cc5a8cebe6 Set id: 8171ecb8-fc2e-4980-8d43-2f03cf972ac8 Version: 6 Effective Time: 20131024 Mutual Pharmaceutical Company, Inc.
No Title 1572449340 ⮝
CIII
Rx only
No Title 1572449341 ⮝
Distributed by:
Par Pharmaceutical
Chestnut Ridge, NY 10977OS2337H-01-1-03
Revised: 04/19
Principal Display Panel - 300 Mg/15 Mg ⮝
ACETAMINOPHEN AND CODEINE
acetaminophen and codeine phosphate tablet
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0603-2337 Route of Administration ORAL DEA Schedule CIII
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CODEINE PHOSPHATE (UNII: GSL05Y1MN6) (CODEINE ANHYDROUS - UNII:UX6OWY2V7J) CODEINE PHOSPHATE 15 mg ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 300 mg
Inactive Ingredients Ingredient Name Strength SODIUM METABISULFITE (UNII: 4VON5FNS3C) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POVIDONE (UNII: FZ989GH94E) STARCH, CORN (UNII: O8232NY3SJ) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) STEARIC ACID (UNII: 4ELV7Z65AP)
Product Characteristics Color WHITE Score 2 pieces Shape ROUND Size 10mm Flavor Imprint Code 2063;V;2 Contains
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0603-2337-21 100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 09/30/1988
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA089990 09/30/1988
Labeler - Par Pharmaceutical (011103059) Revised: 9/2019 Document Id: 9f15ad32-b8e7-4e99-bd21-a6be882567c1 Set id: a8ff3132-fd89-49ff-8623-971f01289df7 Version: 30 Effective Time: 20190905 Par Pharmaceutical
No Title 1572448090 ⮝
CIII
Rx only
Description ⮝
Acetaminophen and codeine is supplied in tablet form for oral administration.
Acetaminophen, 4 -hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula:
C8H9NO2 M.W. 151.16
Codeine phosphate, 7,8-didehydro-4,5 -epoxy-3-methoxy-17methylmorphinan-6 -ol phosphate (1:1) (salt) hemihydrate, a white crystalline powder, is a narcotic analgesic and antitussive. It has the following structural formula:
C18H21NO3 H3PO4 H2O M.W. 406.37
Each tablet contains:
acetaminophen 300 mg codeine phosphate 15 mg (Warning: May be habit forming)
ORacetaminophen 300 mg codeine phosphate 30 mg (Warning: May be habit forming)
ORacetaminophen 300 mg codeine phosphate 60 mg (Warning: May be habit forming) In addition, each tablet contains the following inactive ingredients: corn starch, NF; croscarmellose sodium, NF; magnesium stearate, NF; microcrystalline cellulose, NF; polyvinylpyrrolidone; sodium lauryl sulfate, NF; stearic acid, NF.
Clinical Pharmacology ⮝
This product combines the analgesic effects of a centrally acting analgesic, codeine, with a peripherally acting analgesic, acetaminophen.
Pharmacokinetics
The behavior on the individual components is described below.
Codeine
Codeine is readily absorbed from the gastrointestinal tract. It is rapidly distributed from the intravascular spaces to the various body tissues, with preferential uptake by parenchymatous organs such as the liver, spleen and kidney. Codeine crosses the blood-brain barrier, and is found in fetal tissue and breast milk. The plasma concentration does not correlate with brain concentration or relief of pain; however, codeine is not bound to plasma proteins and does not accumulate in body tissues.
The plasma half-life is about 2.9 hours. The elimination of codeine is primarily via the kidneys, and about 90% of an oral dose is excreted by the kidneys within 24 hours of dosing. The urinary secretion products consist of free and glucuronide conjugated codeine (about 70%), free and conjugated norcodeine (about 10%), free and conjugated morphine (about 10%), normorphine (4%), and hydrocodone (1%). The remainder of the dose is excreted in the feces.
At therapeutic doses, the analgesic effect reaches a peak within 2 hours and persists between 4 and 6 hours.
See OVERDOSAGE for toxicity information.
Acetaminophen
Acetaminophen is rapidly absorbed from the gastrointestinal tract and is distributed throughout most body tissues. The plasma half-life is 1.25 to 3 hours, but may be increased by liver damage and following overdosage. Elimination of acetaminophen is principally by liver metabolism (conjugation) and subsequent renal excretion of metabolites. Approximately 85% of an oral dose appears in the urine within 24 hours of administration, most as the glucuronide conjugate, with small amounts of other conjugates and unchanged drug.
See OVERDOSAGE for toxicity information.
Indications And Usage ⮝
Acetaminophen and codeine phosphate tablets are indicated for the relief of mild to moderately severe pain.
Contraindications ⮝
Codeine-containing products are contraindicated for post-operative pain management in children who have undergone tonsillectomy and/or adenoidectomy. This product should not be administered to patients who have previously exhibited hypersensitivity to codeine or acetaminophen.
Warnings ⮝
Hepatotoxicity
Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed 4000 milligrams per day, and often involve more than one acetaminophen-containing product. The excessive intake of acetaminophen may be intentional to cause self-harm or unintentional as patients attempt to obtain more pain relief or unknowingly take other acetaminophen-containing products.
The risk of acute liver failure is higher in individuals with underlying liver disease and in individuals who ingest alcohol while taking acetaminophen.
Instruct patients to look for acetaminophen or APAP on package labels and not to use more than one product that contains acetaminophen. Instruct patients to seek medical attention immediately upon ingestion of more than 4000 milligrams of acetaminophen per day, even if they feel well.
Serious Skin Reactions
Rarely, acetaminophen may cause serious skin reactions such as acute generalized exanthematous pustulosis (AGEP), Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal. Patients should be informed about the signs of serious skin reactions, and use of the drug should be discontinued at the first appearance of skin rash or any other sign of hypersensitivity.
Death Related to Ultra-Rapid Metabolism of Codeine to Morphine
Respiratory depression and death have occurred in children who received codeine in the post-operative period following tonsillectomy and/or adenoidectomy and had evidence of being ultra-rapid metabolizers of codeine (i.e., multiple copies of the gene for cytochrome P450 isoenzyme 2D6 or high morphine concentrations). Deaths have also occurred in nursing infants who were exposed to high levels of morphine in breast milk because their mothers were ultra-rapid metabolizers of codeine (see PRECAUTIONS, Nursing Mothers).
Some individuals may be ultra-rapid metabolizers because of specific CYP2D6 genotype (gene duplications denoted as *1/*1xN or *1/*2xN). The prevalence of this CYP2D6 phenotype varies widely and has been estimated at 0.5 to 1% in Chinese and Japanese, 0.5 to 1% in Hispanics, 1 to 10% in Caucasians, 3% in African Americans, and 16 to 28% in North Africans, Ethiopians, and Arabs. Data are not available for other ethnic groups. These individuals convert codeine into its active metabolite, morphine, more rapidly and completely than other people. This rapid conversion results in higher than expected serum morphine levels. Even at labeled dosage regimens, individuals who are ultra-rapid metabolizers may have life-threatening or fatal respiratory depression or experience signs of overdose (such as extreme sleepiness, confusion, or shallow breathing) (see OVERDOSAGE).
Children with obstructive sleep apnea who are treated with codeine for post-tonsillectomy and/or adenoidectomy pain may be particularly sensitive to the respiratory depressant effects of codeine that has been rapidly metabolized to morphine. Codeine-containing products are contraindicated for post-operative pain management in all pediatric patients undergoing tonsillectomy and/or adenoidectomy (see CONTRAINDICATIONS).
When prescribing codeine-containing products, healthcare providers should choose the lowest effective dose for the shortest period of time and inform patients and caregivers about these risks and the signs of morphine overdose (see OVERDOSAGE).
Hypersensitivity/Anaphylaxis
There have been post-marketing reports of hypersensitivity and anaphylaxis associated with use of acetaminophen. Clinical signs included swelling of the face, mouth, and throat, respiratory distress, urticaria, rash, pruritus, and vomiting. There were infrequent reports of life-threatening anaphylaxis requiring emergency medical attention. Instruct patients to discontinue acetaminophen and codeine phosphate tablets, USP immediately and seek medical care if they experience these symptoms. Do not prescribe acetaminophen and codeine phosphate tablets, USP for patients with acetaminophen allergy.
In the presence of head injury or other intracranial lesions, the respiratory depressant effects of codeine and other narcotics may be markedly enhanced, as well as their capacity for elevating cerebrospinal fluid pressure. Narcotics also produce other CNS depressant effects, such as drowsiness, that may further obscure the clinical course of the patients with head injuries.
Codeine or other narcotics may obscure signs on which to judge the diagnosis or clinical course of patients with acute abdominal conditions.
Codeine is habit-forming and potentially abusable. Consequently, the extended use of this product is not recommended.
Alcohol Information
Chronic heavy alcohol abusers may be at increased risk of liver toxicity from excessive acetaminophen use, although reports of this event are rare. Reports almost invariably involve cases of severe chronic alcoholics and the dosages of acetaminophen most often exceed recommended doses and often involve substantial overdose. Professionals should alert their patients who regularly consume large amounts of alcohol not to exceed recommended doses of acetaminophen.
Precautions ⮝
General
Acetaminophen and codeine phosphate tablets should be prescribed with caution in certain special-risk patients, such as the elderly or debilitated, and those with severe impairment of renal or hepatic function, head injuries, elevated intracranial pressure, acute abdominal conditions, hypothyroidism, urethral stricture, Addison's disease, or prostatic hypertrophy.
Information for Patients/Caregivers
- Do not take acetaminophen and codeine phosphate tablets, USP if you are allergic to any of its ingredients.
- If you develop signs of allergy such as a rash or difficulty breathing stop taking acetaminophen and codeine phosphate tablets, USP and contact your healthcare provider immediately.
- Do not take more than 4000 milligrams of acetaminophen per day. Call your doctor if you took more than the recommended dose.
Advise patients that some people have a genetic variation that results in codeine changing into morphine more rapidly and completely than other people. Most people are unaware of whether they are an ultra-rapid codeine metabolizer or not. These higher-than-normal levels of morphine in the blood may lead to life-threatening or fatal respiratory depression or signs of overdose such as extreme sleepiness, confusion, or shallow breathing. Children with this genetic variation who were prescribed codeine after tonsillectomy and/or adenoidectomy for obstructive sleep apnea may be at greatest risk based on reports of several deaths in this population due to respiratory depression. Codeine-containing products are contraindicated in all children who undergo tonsillectomy and/or adenoidectomy. Advise caregivers of children receiving codeine-containing products for other reasons to monitor for signs of respiratory depression.
Nursing mothers taking codeine can also have higher morphine levels in their breast milk if they are ultra-rapid metabolizers. These higher levels of morphine in breast milk may lead to life-threatening or fatal side effects in nursing babies. Instruct nursing mothers to watch for signs of morphine toxicity in their infants including increased sleepiness (more than usual), difficulty breastfeeding, breathing difficulties, or limpness. Instruct nursing mothers to talk to the baby's doctor immediately if they notice these signs and, if they cannot reach the doctor right away, to take the baby to an emergency room or call 911 (or local emergency services).
Codeine may impair mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery. Such tasks should be avoided while taking this product.
Alcohol and other CNS depressants may produce an additive CNS depression, when taken with this combination product, and should be avoided.
Codeine may be habit-forming. Patients should take the drug only for as long as it is prescribed, in the amounts prescribed, and no more frequently than prescribed.
Laboratory Tests
In patients with severe hepatic or renal disease, effects of therapy should be monitored with serial liver and/or renal function tests.
Drug Interactions
This drug may enhance the effects of: other narcotic analgesics, alcohol, general anesthetics, tranquilizers such as chlordiazepoxide, sedative-hypnotics, or other CNS depressants, causing increased CNS depression.
Drug/Laboratory Test Interactions
Codeine may increase serum amylase levels.
Acetaminophen may produce false-positive test results for urinary 5-hydroxyindoleacetic acid.
Carcinogenesis, Mutagenesis, Impairment of Fertility
No adequate studies have been conducted in animals to determine whether acetaminophen and codeine have a potential for carcinogenesis or mutagenesis. No adequate studies have been conducted in animals to determine whether acetaminophen has a potential for impairment of fertility.
Acetaminophen and codeine have been found to have no mutagenic potential using the Ames Salmonella-Microsomal Activation test, the Basc test on Drosophila germ cells, and Micronucleus test on mouse bone marrow.
Pregnancy
Teratogenic Effects
Pregnancy Category C
Codeine
A study in rats and rabbits reported no teratogenic effect of codeine administered during the period of organogenesis in doses ranging from 5 to 120 mg/kg. In the rat, doses at the 120 mg/kg level, in the toxic range for the adult animal, were associated with an increase in embryo resorption at the time of implantation. In another study a single 100 mg/kg dose of codeine administered to pregnant mice reportedly resulted in delayed ossification in the offspring.
There are no adequate and well-controlled studies in pregnant women. Acetaminophen and codeine phosphate should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Nonteratogenic Effects
Dependence has been reported in newborns whose mothers took opiates regularly during pregnancy. Withdrawal signs include irritability, excessive crying, tremors, hyperreflexia, fever, vomiting, and diarrhea. These signs usually appear during the first few days of life.
Labor and Delivery
Narcotic analgesics cross the placental barrier. The closer to delivery and the larger the dose used, the greater the possibility of respiratory depression in the newborn. Narcotic analgesics should be avoided during labor if delivery of a premature infant is anticipated. If the mother has received narcotic analgesics during labor, newborn infants should be observed closely for signs of respiratory depression. Resuscitation may be required (see OVERDOSAGE). The effect of codeine, if any, on the later growth, development, and functional maturation of the child is unknown.
Nursing Mothers
Acetaminophen is excreted in breast milk in small amounts, but the significance of its effects on nursing infants is not known. Because of the potential for serious adverse reactions in nursing infants from acetaminophen, a decision should be made whether to discontinue the drug, taking into account the importance of the drug to the mother.
Codeine is secreted into human milk. In women with normal codeine metabolism (normal CYP2D6 activity), the amount of codeine secreted into human milk is low and dose-dependent. Despite the common use of codeine products to manage postpartum pain, reports of adverse events in infants are rare. However, some women are ultra-rapid metabolizers of codeine. These women achieve higher-than-expected serum levels of codeine's active metabolite, morphine, leading to higher-than-expected levels of morphine in breast milk and potentially dangerously high serum morphine levels in their breastfed infants. Therefore, maternal use of codeine can potentially lead to serious adverse reactions, including death, in nursing infants.
The risk of infant exposure to codeine and morphine through breast milk should be weighed against the benefits of breastfeeding for both the mother and baby. Caution should be exercised when codeine is administered to a nursing woman. If a codeine-containing product is selected, the lowest dose should be prescribed for the shortest period of time to achieve the desired clinical effect. Mothers using codeine should be informed about when to seek immediate medical care and how to identify the signs and symptoms of neonatal toxicity, such as drowsiness or sedation, difficulty breastfeeding, breathing difficulties, and decreased tone, in their baby. Nursing mothers who are ultra-rapid metabolizers may also experience overdose symptoms such as extreme sleepiness, confusion or shallow breathing. Prescribers should closely monitor mother-infant pairs and notify treating pediatricians about the use of codeine during breastfeeding (see WARNINGS, Death Related to Ultra-Rapid Metabolism of Codeine to Morphine).
Pediatric Use
Respiratory depression and death have occurred in children with obstructive sleep apnea who received codeine in the post-operative period following tonsillectomy and/or adenoidectomy and had evidence of being ultra-rapid metabolizers of codeine (i.e., multiple copies of the gene for cytochrome P450 isoenzyme CYP2D6 or high morphine concentrations). These children may be particularly sensitive to the respiratory depressant effects of codeine that has been rapidly metabolized to morphine. Codeine-containing products are contraindicated for post-operative pain management in all pediatric patients undergoing tonsillectomy and/or adenoidectomy (see CONTRAINDICATIONS and WARNINGS).
Adverse Reactions ⮝
The most frequently reported adverse reactions are drowsiness, lightheadedness, dizziness, sedation, shortness of breath, nausea and vomiting. These effects seem to be more prominent in ambulatory than in non-ambulatory patients, and some of these adverse reactions may be alleviated if the patient lies down.
Other adverse reactions include allergic reactions, euphoria, dysphoria, constipation, abdominal pain, pruritus, rash, thrombocytopenia, agranulocytosis.
At higher doses codeine has most of the disadvantages of morphine including respiratory depression.
Drug Abuse And Dependence ⮝
Controlled Substance
Acetaminophen and codeine phosphate tablets are classified as a Schedule III controlled substance.
Abuse and Dependence
Codeine can produce drug dependence of the morphine type and, therefore, has the potential for being abused. Psychological dependence, physical dependence, and tolerance may develop upon repeated administration and it should be prescribed and administered with the same degree of caution appropriate to the use of other oral narcotic medications.
Overdosage ⮝
Following an acute overdosage, toxicity may result from codeine or acetaminophen.
Signs and Symptoms
Toxicity from codeine poisoning includes the opioid triad of: pinpoint pupils, depression of respiration, and loss of consciousness. Convulsions may occur.
In acetaminophen overdosage: dose-dependent, potentially fatal hepatic necrosis is the most serious adverse effect. Renal tubular necrosis, hypoglycemic coma, and coagulation defects may also occur. Early symptoms following a potentially hepatotoxic overdose may include: nausea, vomiting, diaphoresis and general malaise. Clinical and laboratory evidence of hepatic toxicity may not be apparent until 48 to 72 hours post-ingestion.
Treatment
A single or multiple drug overdose with acetaminophen and codeine is a potentially lethal polydrug overdose, and consultation with a regional poison control center is recommended. Immediate treatment includes support of cardiorespiratory function and measures to reduce drug absorption.
Oxygen, intravenous fluids, vasopressors, and other supportive measures should be employed as indicated. Assisted or controlled ventilation should also be considered. For respiratory depression due to overdosage or unusual sensitivity to codeine, parenteral naloxone is a specific and effective antagonist.
Gastric decontamination with activated charcoal should be administered just prior to N-acetylcysteine (NAC) to decrease systemic absorption if acetaminophen ingestion is known or suspected to have occurred within a few hours of presentation. Serum acetaminophen levels should be obtained immediately if the patient presents 4 hours or more after ingestion to assess potential risk of hepatotoxicity; acetaminophen levels drawn less than 4 hours post-ingestion may be misleading. To obtain the best possible outcome, NAC should be administered as soon as possible where impending or evolving liver injury is suspected. Intravenous NAC may be administered when circumstances preclude oral administration.
Vigorous supportive therapy is required in severe intoxication. Procedures to limit the continuing absorption of the drug must be readily performed since the hepatic injury is dose-dependent and occurs early in the course of intoxication.
Dosage And Administration ⮝
Dosage should be adjusted according to severity of pain and response of the patient.
The usual adult dosage is:
Single Doses (range) Maximum 24 Hour Dose Codeine Phosphate 15 mg to 60 mg 360 mg Acetaminophen 300 mg to 1000 mg 4000 mg The usual dose of codeine phosphate in children is 0.5 mg/kg.
Doses may be repeated up to every 4 hours.
The prescriber must determine the number of tablets per dose, and the maximum number of tablets per 24 hours based upon the above dosage guidance. This information should be conveyed in the prescription.
It should be kept in mind, however, that tolerance to codeine can develop with continued use and that the incidence of untoward effects is dose related. Adult doses of codeine higher than 60 mg fail to give commensurate relief of pain but merely prolong analgesia and are associated with an appreciably increased incidence of undesirable side effects. Equivalently high doses in children would have similar effects.
How Supplied ⮝
Acetaminophen and codeine phosphate tablets (300 mg/15 mg) white, round, unscored, debossed MP 111 on one side and 2 on the other side.
Available as follows:
Bottles of 50 NDC 53489-159-02 Bottles of 100 NDC 53489-159-01 Bottles of 500 NDC 53489-159-05 Bottles of 1000 NDC 53489-159-10 Acetaminophen and codeine phosphate tablets (300 mg/30 mg) white, round, unscored, debossed MP 122 on one side and 3 on the other side.
Available as follows:
Bottles of 50 NDC 53489-160-02 Bottles of 100 NDC 53489-160-01 Bottles of 500 NDC 53489-160-05 Bottles of 1000 NDC 53489-160-10 Acetaminophen and codeine phosphate tablets (300 mg/60 mg) white, round, unscored, debossed MP 127 on one side and 4 on the other side.
Available as follows:
Bottles of 50 NDC 53489-161-02 Bottles of 100 NDC 53489-161-01 Bottles of 500 NDC 53489-161-05 Bottles of 1000 NDC 53489-161-10 Store at 20 to 25 C (68 to 77 F).
[See USP Controlled Room Temperature]
DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER.
This Is An Image Of The Label For 300 Mg/30 Mg Acetaminophen And Codeine Phosphate Tablets. ⮝
ACETAMINOPHEN AND CODEINE
acetaminophen and codeine phosphate tablet
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68387-250(NDC:0603-2338) Route of Administration ORAL DEA Schedule CIII
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 300 mg CODEINE PHOSPHATE (UNII: GSL05Y1MN6) (CODEINE - UNII:Q830PW7520) CODEINE PHOSPHATE 30 mg
Inactive Ingredients Ingredient Name Strength MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POVIDONE (UNII: FZ989GH94E) STARCH, CORN (UNII: O8232NY3SJ) SODIUM METABISULFITE (UNII: 4VON5FNS3C) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) STEARIC ACID (UNII: 4ELV7Z65AP)
Product Characteristics Color WHITE Score 2 pieces Shape ROUND Size 10mm Flavor Imprint Code 2064;V;3 Contains
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68387-250-15 15 in 1 BOTTLE, PLASTIC 2 NDC:68387-250-30 30 in 1 BOTTLE, PLASTIC 3 NDC:68387-250-40 40 in 1 BOTTLE, PLASTIC 4 NDC:68387-250-60 60 in 1 BOTTLE, PLASTIC 5 NDC:68387-250-90 90 in 1 BOTTLE, PLASTIC
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA089805 03/19/2009
Labeler - Keltman Pharmaceuticals Inc. (362861077)
Establishment Name Address ID/FEI Business Operations Sandhills Packaging 825138717 repack Revised: 8/2010 Document Id: 813e328e-b953-413e-b467-33e71b9211db Set id: f94eb4bf-c577-4fa3-bfba-a12a6b821174 Version: 1 Effective Time: 20100809 Keltman Pharmaceuticals Inc.
No Title 1572449615 ⮝
CIII
Rx only
No Title 1572449616 ⮝
Dispense in a tight, light resistant container as defined in the USP/NF.
Store at 20 to 25 C (68 to 77 F) [see USP Controlled Room Temperature].
Principal Display Panel ⮝
ACETAMINOPHEN AND CODEINE
acetaminophen and codeine phosphate tablet
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0440-7026(NDC:0603-2338) Route of Administration ORAL DEA Schedule CIII
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CODEINE PHOSPHATE (UNII: GSL05Y1MN6) (CODEINE ANHYDROUS - UNII:UX6OWY2V7J) CODEINE PHOSPHATE 30 mg ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 300 mg
Inactive Ingredients Ingredient Name Strength MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POVIDONES (UNII: FZ989GH94E) STARCH, CORN (UNII: O8232NY3SJ) SODIUM METABISULFITE (UNII: 4VON5FNS3C) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) STEARIC ACID (UNII: 4ELV7Z65AP)
Product Characteristics Color WHITE Score 2 pieces Shape ROUND Size 10mm Flavor Imprint Code 2064;V;3 Contains
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0440-7026-30 30 in 1 BOTTLE, PLASTIC 2 NDC:0440-7026-40 40 in 1 BOTTLE, PLASTIC
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA089805 09/30/1988
ACETAMINOPHEN AND CODEINE
acetaminophen and codeine phosphate tablet
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0440-7027(NDC:0603-2339) Route of Administration ORAL DEA Schedule CIII
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CODEINE PHOSPHATE (UNII: GSL05Y1MN6) (CODEINE ANHYDROUS - UNII:UX6OWY2V7J) CODEINE PHOSPHATE 60 mg ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 300 mg
Inactive Ingredients Ingredient Name Strength MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POVIDONES (UNII: FZ989GH94E) STARCH, CORN (UNII: O8232NY3SJ) SODIUM METABISULFITE (UNII: 4VON5FNS3C) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) STEARIC ACID (UNII: 4ELV7Z65AP)
Product Characteristics Color WHITE Score 2 pieces Shape ROUND Size 12mm Flavor Imprint Code 2065;V;4 Contains
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0440-7027-30 30 in 1 BOTTLE, PLASTIC 2 NDC:0440-7027-40 40 in 1 BOTTLE, PLASTIC
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA089828 09/30/1988
Labeler - Liberty Pharmaceuticals, Inc. (012568840) Revised: 2/2014 Document Id: c688f809-80eb-4375-b1d5-1826d83c3c27 Set id: 1e522939-4af2-4a28-b92d-a2435cbbc521 Version: 1 Effective Time: 20140210 Liberty Pharmaceuticals, Inc.
No Title 1572450115 ⮝
CIII
Rx only
No Title 1572450396 ⮝
CIII
Rx only
Description ⮝
Acetaminophen and codeine is supplied in tablet form for oral administration.
Acetaminophen, 4'-hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula:
Codeine phosphate, 7,8-didehydro-4,5 -epoxy-3-methoxy-17methylmorphinan-6 -ol phosphate (1:1) (salt) hemihydrate, a white crystalline powder, is a narcotic analgesic and antitussive. It has the following structural formula:
Each 300 mg/30 mg Acetaminophen and Codeine Phosphate Tablet contains:
Acetaminophen ......................................................................................................300 mg
Codeine Phosphate ..................................................................................................30 mgIn addition each tablet contains the following inactive ingredients: magnesium stearate, microcrystalline cellulose, povidone, pregelatinized corn starch, sodium metabisulfite, sodium starch glycolate and stearic acid.
Storage And Handling ⮝
Dispense in a tight, light resistant container as defined in the USP/NF.
Store at 20 to 25 C (68 to 77 F) [see USP Controlled Room Temperature].
Manufactured for:
QUALITEST PHARMACEUTICALS
Huntsville, AL 35811Marketed/ Packaged by:
Blenheim Pharmacal, Inc.
North Blenheim, NY 12131, (USA)8182436
R11/07-R2
Package/label Display Panel - 300mg/ 30mg 20s ⮝
Bottle Label 10544-100-20
ACETAMINOPHEN AND CODEINE
acetaminophen and codeine phosphate tablet
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:10544-100(NDC:0603-2338) Route of Administration ORAL
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 300 mg CODEINE PHOSPHATE (UNII: GSL05Y1MN6) (CODEINE ANHYDROUS - UNII:UX6OWY2V7J) CODEINE PHOSPHATE 30 mg
Inactive Ingredients Ingredient Name Strength MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POVIDONES (UNII: FZ989GH94E) STARCH, CORN (UNII: O8232NY3SJ) SODIUM METABISULFITE (UNII: 4VON5FNS3C) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) STEARIC ACID (UNII: 4ELV7Z65AP)
Product Characteristics Color white Score 2 pieces Shape ROUND Size 10mm Flavor Imprint Code 2064;V;3 Contains
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10544-100-10 10 in 1 BOTTLE 2 NDC:10544-100-15 15 in 1 BOTTLE 3 NDC:10544-100-20 20 in 1 BOTTLE
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA089805 11/11/2013
Labeler - Blenheim Pharmacal, Inc. (171434587)
Registrant - Blenheim Pharmacal, Inc. (171434587)
Establishment Name Address ID/FEI Business Operations Blenheim Pharmacal, Inc. 171434587 RELABEL(10544-100) , REPACK(10544-100) Revised: 12/2013 Document Id: 21c498e0-47f1-4958-9126-86ddde5f2d78 Set id: fdea5078-b6d3-4c2b-981b-398bb1fadc40 Version: 4 Effective Time: 20131231 Blenheim Pharmacal, Inc.
No Title 1572451860 ⮝
CIII
Rx Only
Principal Display Panel - 300 Mg/60 Mg ⮝
ACETAMINOPHEN AND CODEINE
acetaminophen and codeine phosphate tablet
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0603-2338 Route of Administration ORAL DEA Schedule CIII
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CODEINE PHOSPHATE (UNII: GSL05Y1MN6) (CODEINE ANHYDROUS - UNII:UX6OWY2V7J) CODEINE PHOSPHATE 30 mg ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 300 mg
Inactive Ingredients Ingredient Name Strength MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POVIDONE (UNII: FZ989GH94E) STARCH, CORN (UNII: O8232NY3SJ) SODIUM METABISULFITE (UNII: 4VON5FNS3C) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) STEARIC ACID (UNII: 4ELV7Z65AP)
Product Characteristics Color WHITE Score 2 pieces Shape ROUND Size 10mm Flavor Imprint Code 2064;V;3 Contains
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0603-2338-16 30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 09/30/1988 10/31/2017 2 NDC:0603-2338-20 60 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 09/30/1988 10/31/2017 3 NDC:0603-2338-02 90 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 09/30/1988 10/31/2017 4 NDC:0603-2338-21 100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 09/30/1988 5 NDC:0603-2338-22 120 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 09/30/1988 10/31/2017 6 NDC:0603-2338-04 180 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 09/30/1988 10/31/2017 7 NDC:0603-2338-32 1000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 09/30/1988
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA089805 09/30/1988
ACETAMINOPHEN AND CODEINE
acetaminophen and codeine phosphate tablet
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0603-2339 Route of Administration ORAL DEA Schedule CIII
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CODEINE PHOSPHATE (UNII: GSL05Y1MN6) (CODEINE ANHYDROUS - UNII:UX6OWY2V7J) CODEINE PHOSPHATE 60 mg ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 300 mg
Inactive Ingredients Ingredient Name Strength MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POVIDONE (UNII: FZ989GH94E) STARCH, CORN (UNII: O8232NY3SJ) SODIUM METABISULFITE (UNII: 4VON5FNS3C) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) STEARIC ACID (UNII: 4ELV7Z65AP)
Product Characteristics Color WHITE Score 2 pieces Shape ROUND Size 12mm Flavor Imprint Code 2065;V;4 Contains
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0603-2339-21 100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 09/30/1988 2 NDC:0603-2339-28 500 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 09/30/1988
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA089828 09/30/1988
Labeler - Par Pharmaceutical (011103059) Revised: 5/2019 Document Id: 3809e549-9586-4a30-b20b-a01c08d9869d Set id: afb118ae-3841-4d0a-aef4-17f05cb6f9be Version: 25 Effective Time: 20190506 Par Pharmaceutical
No Title 1572452292 ⮝
CIII
Rx only
Acetaminophen And Codeine Phosphate Tablets, Usp300 Mg/30 Mg ⮝
CIII
Rx only
No Title 1572453226 ⮝
BOXED WARNING
Hepatotoxicity:
Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed 4000 milligrams per day, and often involve more than one acetaminophen-containing product.
WARNING:
Death Related to Ultra-Rapid Metabolism of Codeine to Morphine Respiratory depression and death have occurred in children who received codeine following tonsillectomy and/or adenoidectomy and had evidence of being ultra-rapid metabolizers of codeine due to a CYP2D6 polymorphism.
No Title 1572457195 ⮝
CIII
Rx only
Repackaging Information ⮝
Please reference the How Supplied section listed above for a description of individual tablets or capsules. This drug product has been received by Aphena Pharma - TN in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from Aphena are listed below:
Count 30/300mg 60/300mg 15 67544-882-15 - 20 67544-882-20 - 30 67544-882-30 67544-474-30 40 67544-882-40 - 45 67544-882-45 - 50 67544-882-50 - 60 67544-882-53 67544-474-53 75 67544-882-55 - 90 67544-882-60 67544-474-60 120 67544-882-70 67544-474-70 150 67544-882-75 - 180 67544-882-80 67544-474-80 240 67544-882-90 67544-474-90 Store between 20 -25 C (68 -77 F). See USP Controlled Room Temperature. Dispense in a tight light-resistant container as defined by USP. Keep this and all drugs out of the reach of children.
Repackaged by:
Cookeville, TN 38506
20130605AW
Principal Display Panel - 30/300mg ⮝
NDC 67544-882 - Codeine Phosphate/APAP 30/300mg - Rx Only
Principal Display Panel - 60/300mg ⮝
NDC 67544-474 - Codeine Phosphate/APAP 60/300mg - Rx Only
ACETAMINOPHEN AND CODEINE
acetaminophen and codeine phosphate tablet
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:67544-882(NDC:0603-2338) Route of Administration ORAL DEA Schedule CIII
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CODEINE PHOSPHATE (UNII: GSL05Y1MN6) (CODEINE ANHYDROUS - UNII:UX6OWY2V7J) CODEINE PHOSPHATE 30 mg ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 300 mg
Inactive Ingredients Ingredient Name Strength MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POVIDONES (UNII: FZ989GH94E) STARCH, CORN (UNII: O8232NY3SJ) SODIUM METABISULFITE (UNII: 4VON5FNS3C) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) STEARIC ACID (UNII: 4ELV7Z65AP)
Product Characteristics Color WHITE Score 2 pieces Shape ROUND Size 10mm Flavor Imprint Code 2064;V;3 Contains
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:67544-882-15 15 in 1 BOTTLE, PLASTIC 2 NDC:67544-882-20 20 in 1 BOTTLE, PLASTIC 3 NDC:67544-882-30 30 in 1 BOTTLE, PLASTIC 4 NDC:67544-882-40 40 in 1 BOTTLE, PLASTIC 5 NDC:67544-882-45 45 in 1 BOTTLE, PLASTIC 6 NDC:67544-882-50 50 in 1 BOTTLE, PLASTIC 7 NDC:67544-882-53 60 in 1 BOTTLE, PLASTIC 8 NDC:67544-882-55 75 in 1 BOTTLE, PLASTIC 9 NDC:67544-882-60 90 in 1 BOTTLE, PLASTIC 10 NDC:67544-882-70 120 in 1 BOTTLE, PLASTIC 11 NDC:67544-882-75 150 in 1 BOTTLE, PLASTIC 12 NDC:67544-882-80 180 in 1 BOTTLE, PLASTIC 13 NDC:67544-882-90 240 in 1 BOTTLE, PLASTIC
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA089805 09/30/1988
ACETAMINOPHEN AND CODEINE
acetaminophen and codeine phosphate tablet
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:67544-474(NDC:0603-2339) Route of Administration ORAL DEA Schedule CIII
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CODEINE PHOSPHATE (UNII: GSL05Y1MN6) (CODEINE ANHYDROUS - UNII:UX6OWY2V7J) CODEINE PHOSPHATE 60 mg ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 300 mg
Inactive Ingredients Ingredient Name Strength MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POVIDONES (UNII: FZ989GH94E) STARCH, CORN (UNII: O8232NY3SJ) SODIUM METABISULFITE (UNII: 4VON5FNS3C) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) STEARIC ACID (UNII: 4ELV7Z65AP)
Product Characteristics Color WHITE Score 2 pieces Shape ROUND Size 12mm Flavor Imprint Code 2065;V;4 Contains
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:67544-474-30 30 in 1 BOTTLE, PLASTIC 2 NDC:67544-474-53 60 in 1 BOTTLE, PLASTIC 3 NDC:67544-474-60 90 in 1 BOTTLE, PLASTIC 4 NDC:67544-474-70 120 in 1 BOTTLE, PLASTIC 5 NDC:67544-474-80 180 in 1 BOTTLE, PLASTIC 6 NDC:67544-474-90 240 in 1 BOTTLE, PLASTIC
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA089828 09/30/1988
Labeler - Aphena Pharma Solutions - Tennessee, LLC (128385585)
Establishment Name Address ID/FEI Business Operations Aphena Pharma Solutions - Tennessee, LLC 128385585 Repack(67544-882, 67544-474) Revised: 6/2013 Document Id: 6d0a1553-38cf-41c5-a7a4-1d738112d94c Set id: 1afe1bb3-6903-4785-a121-ac8aae8653a7 Version: 1 Effective Time: 20130605 Aphena Pharma Solutions - Tennessee, LLC
No Title 1572457503 ⮝
CIII
Rx only
No Title 1572457547 ⮝
CIII
Rx only