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ACETAMINOPHEN, CAFFEINE, DIHYDROCODEINE BITARTRATE capsule


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

Patient Information 

Dihydrocodeine Bitartrate, Caffeine, Acetaminophen Capsules, CIII

Dihydrocodeine Bitartrate, Caffeine, Acetaminophen Is: 

  • A strong prescription pain medicine that contains an opioid (narcotic) that is used to manage moderate to moderately severe 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 Dihydrocodeine Bitartrate, Caffeine, Acetaminophen: 

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

Important Information Guiding Use In Pediatric Patients: 

  • Do not give Dihydrocodeine Bitartrate, Caffeine, Acetaminophen to a child younger than 12 years of age.
  • Do not give Dihydrocodeine Bitartrate, Caffeine, Acetaminophen to a child younger than 18 years of age after surgery to remove the tonsils and/or adenoids.
  • Avoid giving Dihydrocodeine Bitartrate, Caffeine, Acetaminophen 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 Dihydrocodeine Bitartrate, Caffeine, Acetaminophen If You Have: 

  • severe asthma, trouble breathing, or other lung problems.
  • a bowel blockage or have narrowing of the stomach or intestines.
  • previously had an allergic reaction to dihydrocodeine or acetaminophen.

Before Taking Dihydrocodeine Bitartrate, Caffeine, Acetaminophen, 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 becomepregnant. Prolonged use of Dihydrocodeine Bitartrate, Caffeine, Acetaminophen 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 Dihydrocodeine Bitartrate, Caffeine, Acetaminophen with certain other medicines can cause serious side effects that could lead to death.

When taking Dihydrocodeine Bitartrate, Caffeine, Acetaminophen:

  • Do not change your dose. Take Dihydrocodeine Bitartrate, Caffeine, Acetaminophen exactly as prescribed by your healthcare provider. Use the lowest dose possible for the shortest time needed.
  • Take your prescribed dose of 2 Dihydrocodeine Bitartrate, Caffeine, Acetaminophen capsules orally every 4 hours, as needed. 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 Dihydrocodeine Bitartrate, Caffeine, Acetaminophen regularly, do not stop taking Dihydrocodeine Bitartrate, Caffeine, Acetaminophen without talking to your healthcare provider.
  • After you stop taking Dihydrocodeine Bitartrate, Caffeine, Acetaminophen, dispose the unused Dihydrocodeine Bitartrate, Caffeine, Acetaminophen in accordance with local state guidelines and/or regulations.

While taking Dihydrocodeine Bitartrate, Caffeine, Acetaminophen

DO NOT:

  • Drive or operate heavy machinery, until you know how Dihydrocodeine Bitartrate, Caffeine, Acetaminophen affects you. Dihydrocodeine Bitartrate, Caffeine, Acetaminophen 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 Dihydrocodeine Bitartrate, Caffeine, Acetaminophen may cause you to overdose and die.

The Possible Side Effects Of Dihydrocodeine Bitartrate, Caffeine, Acetaminophen: 

  • 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 Dihydrocodeine Bitartrate, Caffeine, Acetaminophen. 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

Manufactured for:
Xspire Pharma
121 Marketridge Drive, Suite B
Ridgeland, MS 39157

www.xspirerx.com.com or call 1-888-252-3901

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Issued: 7/2017



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