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ASCOMP WITH CODEINE- butalbital, aspirin, cafeine, and codeine phosphate capsule


  1. Ascomp With Codeine Is:
  2. Important Information About Ascomp With Codeine:
  3. Important Information Guiding Use In Pediatric Patients:
  4. Do Not Take Ascomp With Codeine If You Have:
  5. Before Taking Ascomp With Codeine, Tell Your Healthcare Provider If You Have A History Of:
  6. Tell Your Healthcare Provider If You Are:
  7. When Taking Ascomp With Codeine:
  8. While Taking Ascomp With Codeine Do Not:
  9. The Possible Side Effects Of Ascomp With Codeine:
  10. Get Emergency Medical Help If You Have:
  11. Patient Information

Ascomp With Codeine Is: 

A strong prescription pain medicine that contains an opioid (narcotic) that is indicated for the relief of the symptom complex of tension (or muscle contraction) headache, 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 Ascomp With Codeine: 

Get emergency help right away if you take too much ASCOMP with CODEINE (overdose).When you first start taking ASCOMP with CODEINE, 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 ASCOMP with CODEINE 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 ASCOMP with CODEINE. They could die from taking it. Store ASCOMP with CODEINE away from children and in a safe place to prevent stealing or abuse. Selling or giving away ASCOMP with CODEINE is against the law.

Important Information Guiding Use In Pediatric Patients: 

Do not give ASCOMP with CODEINE to a child younger than 12 years of age.
Do not give ASCOMP with CODEINE to a child younger than 18 years of age after surgery to remove the tonsils and/or adenoids.
Avoid giving ASCOMP with CODEINE 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 give ASCOMP with CODEINE to a child or teenager with a viral illness. Reye syndrome, a life-threatening condition, can happen when aspirin (an ingredient in ASCOMP with CODEINE) is used in children and teenagers who have certain viral illnesses.

Do Not Take Ascomp With Codeine If You Have: 

severe asthma, trouble breathing, or other lung problems.
a bowel blockage or have narrowing of the stomach or intestines.
known allergy to nonsteroidal anti-inflammatory drug products (NSAIDs).
a rare disorder in which your blood doesn t clot normally (hemophilia).

Before Taking Ascomp With Codeine, Tell Your Healthcare Provider If You Have A History Of: 

head injury, seizures
problems urinating
liver, kidney, thyroid problems
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. ASCOMP with CODEINE may harm your unborn baby. Prolonged use of ASCOMP with CODEINE 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.Taking ASCOMP with CODEINE with certain other medicines can cause serious side effects that could lead to death.

When Taking Ascomp With Codeine: 

Do not change your dose. Take ASCOMP with CODEINE exactly as prescribed by your healthcare provider. Use the lowest dose possible for the shortest time needed.
Take your prescribed dose of 1 or 2 capsules every 4 hours. Total daily dosage should not exceed 6 capsules. Do not take more than your prescribed dose. If you miss a dose, take your next dose at your usual time.
Call your healthcare provider if the dose you are taking does not control your pain.
If you have been taking ASCOMP with CODEINE regularly, do not stop taking ASCOMP with CODEINE without talking to your healthcare provider.
After you stop taking ASCOMP with CODEINE, dispose the unused ASCOMP with CODEINE in accordance with the local state guidelines and/or regulations.

While Taking Ascomp With Codeine Do Not: 

Drive or operate heavy machinery until you know how ASCOMP with CODEINE affects you. ASCOMP with CODEINE 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 ASCOMP with CODEINE may cause you to overdose and die.

The Possible Side Effects Of Ascomp With Codeine: 

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.
If you are a nursing mother taking ASCOMP with CODEINE and your breastfeeding baby has increased sleepiness, confusion, difficulty breathing, shallow breathing, limpness, or difficulty breastfeeding.

These are not all the possible side effects of ASCOMP with CODEINE. 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

This Medication Guide has been approved by the U.S. Food and Drug Administration. Issued: 09/2019

Patient Information 

Advise the patient to read the FDA-approved patient labeling(MEDICATION GUIDE).

Addiction, Abuse, and Misuse

Inform patients that the use of ASCOMP with CODEINE, even when taken as recommended, can result in addiction, abuse, and misuse, which can lead to overdose and death[seeWarnings and Precautions (5.1)].Instruct patients not to share ASCOMP with CODEINE with others and to take steps to protect ASCOMP with CODEINE from theft or misuse.

Life-Threatening Respiratory Depression

Inform patients of the risk of life-threatening respiratory depression, including information that the risk is greatest when starting ASCOMP with CODEINE or when the dosage is increased, and that it can occur even at recommended dosages[seeWarnings and Precautions (5.3)]. Advise patients how to recognize respiratory depression and to seek medical attention if breathing difficulties develop.

Accidental Ingestion

Inform patients that accidental ingestion, especially by children, may result in respiratory depression or death. Instruct patients to take steps to store ASCOMP with CODEINE securely and to properly dispose of unused ASCOMP with CODEINE in accordance with the local state guidelines and/or regulations.

Risks from Concomitant Use with Benzodiazepines and Other CNS Depressants

Inform patients and caregivers that potentially fatal additive effects may occur if ASCOMP with CODEINE is used with benzodiazepines or other CNS depressants, including alcohol, and not to use these concomitantly unless supervised by a health care provider [seeWarnings and Precautions (5.4),Drug Interactions (7)].

Ultra-Rapid Metabolism of Codeine and Other Risk Factors for Life-threatening Respiratory Depression in

Children

Advise caregivers that ASCOMP with CODEINE is contraindicated in all children younger than 12 years of age and in children younger than 18 years of age following tonsillectomy and/or adenoidectomy. Advise caregivers of children 12-18 years of age receiving ASCOMP with CODEINE to monitor for signs of respiratory depression[seeWarnings and Precautions (5.5)].

Serotonin Syndrome

Inform patients that opioids could cause a rare but potentially life-threatening condition resulting from concomitant administration of serotonergic drugs. Warn patients of the symptoms of serotonin syndrome and to seek medical attention right away if symptoms develop. Instruct patients to inform their healthcare providers if they are taking, or plan to take serotonergic medications.[seeDrug Interactions (7)].

MAOI Interaction

Inform patients not to take ASCOMP with CODEINE while using any drugs that inhibit monoamine oxidase. Patients should not start MAOIs while taking ASCOMP with CODEINE [seeDrug Interactions (7)].

Adrenal Insufficiency

Inform patients that opioids could cause adrenal insufficiency, a potentially life-threatening condition. Adrenal insufficiency may present with non-specific symptoms and signs such as nausea, vomiting, anorexia, fatigue, weakness, dizziness, and low blood pressure. Advise patients to seek medical attention if they experience a constellation of these symptoms[seeWarnings and Precautions (5.10)].

Important Administration Instructions

Instruct patients how to properly take ASCOMP with CODEINE.[seeDosage and Administration (2.2)].Patients should take the drug only for as long as it is prescribed, in the amounts prescribed, and no more frequently than prescribed.

Hypotension

Inform patients that ASCOMP with CODEINE may cause orthostatic hypotension and syncope. Instruct patients how to recognize symptoms of low blood pressure and how to reduce the risk of serious consequences should hypotension occur (e.g., sit or lie down, carefully rise from a sitting or lying position)[seeWarnings and Precautions (5.11)].

Anaphylaxis

Inform patients that anaphylaxis has been reported with ingredients contained in ASCOMP with CODEINE. Advise patients how to recognize such a reaction and when to seek medical attention[seeContraindications (4),Adverse Reactions (6)].

Aspirin Allergy

Patients should be informed that ASCOMP with CODEINE contains aspirin and should not be taken by patients with an aspirin or NSAIDs allergy[seeWarnings and Precautions (5.19)].

Pregnancy

Neonatal Opioid Withdrawal Syndrome

Inform female patients of reproductive potential that prolonged use of ASCOMP with CODEINE during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated[seeWarnings and Precautions (5.6),Use in Specific Populations (8.1)].

Embryo-Fetal Toxicity

Inform female patients of reproductive potential that ASCOMP with CODEINE can (or may) cause fetal harm and to inform the healthcare provider of a known or suspected pregnancy[seeUse in Specific Populations (8.1)].

Lactation

Advise women that breastfeeding is not recommended during treatment with ASCOMP with CODEINE[seeUse in Specific Populations (8.2)].

Infertility

Inform patients that chronic use of opioids may cause reduced fertility. It is not known whether these effects on fertility are reversible[seeUse in Specific Populations (8.3)].

Risk of Bleeding

Inform patients about the signs and symptoms of bleeding. Tell patients to notify their physician if they are prescribed any drug which may increase risk of bleeding.

Counsel patients who consume three or more alcoholic drinks daily about the bleeding risks involved with chronic, heavy alcohol use while taking aspirin[seeWarnings and Precautions (5.17)].

Driving or Operating Heavy Machinery

Inform patients that ASCOMP with CODEINE may impair the ability to perform potentially hazardous activities such as driving a car or operating heavy machinery. Advise patients not to perform such tasks until they know how they will react to the medication[seeWarnings and Precautions (5.16)].

Constipation

Advise patients of the potential for severe constipation, including management instructions and when to seek medical attention[seeAdverse Reactions (6)].

Disposal of Unused ASCOMP with CODEINE

Advise patients to properly dispose of unused ASCOMP with CODEINE. Advise patients to throw the drug in the household trash following these steps. 1) Remove them from their original containers and mix them with an undesirable substance, such as used coffee grounds or kitty litter (this makes the drug less appealing to children and pets, and unrecognizable to people who may intentionally go through the trash seeking drugs); 2) Place the mixture in a sealable bag, empty can, or other container to prevent the drug from leaking or breaking out of a garbage bag, or to dispose of in accordance with the local state guidelines and/or regulations.

Manufactured by: Nexgen Pharma, Inc., Irvine, CA 92606, USA

Rev. 09/2019



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