Acetaminophen and Codeine (Page 10 of 10)

Medication Guide

Medication Guide

Acetaminophen and Codeine Phosphate Tablets USP, CIII

(a seet’ a min’ oh fen and koe’ deen fos’ fate)

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 many acetaminophen and codeine phosphate tablets (overdose). When you first start taking acetaminophen and codeine phosphate 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.
  • Acetaminophen and codeine phosphate tablets can cause severe drowsiness, breathing problems (respiratory depression), coma and death when taken with benzodiazepines or other medicines that depress consciousness.
  • Never give anyone else your acetaminophen and codeine phosphate tablets. They could die from taking it. Store acetaminophen and codeine phosphate tablets away from children and in a safe place to prevent stealing or abuse. Selling or giving away acetaminophen and codeine phosphate tablets is against the law.

Important Information Guiding Use in Pediatric Patients:

  • Do not give acetaminophen and codeine phosphate tablets to a child younger than 12.
  • Do not give acetaminophen and codeine phosphate tablets to a child younger than 18 to treat pain 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

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. Taking 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.
  • After you stop taking acetaminophen and codeine phosphate tablets, to properly dispose of the acetaminophen and codeine phosphate tablets flush them down the toilet or dispose of in accordance with local state guidelines and/or regulations.

While taking acetaminophen and codeine phosphate tablets DO NOT:

  • Drive or operate heavy machinery, until you know how acetaminophen and codeine phosphate 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 phosphate 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

Manufactured by:
Amneal Pharmaceuticals of NY LLC
Brookhaven, NY 11719

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

Rev. 05-2017-05

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

100 mg/30 mg Label
(click image for full-size original)

ACETAMINOPHEN AND CODEINE
acetaminophen and codeine tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:67046-908(NDC:65162-033)
Route of Administration ORAL DEA Schedule CIII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 300 mg
CODEINE PHOSPHATE (CODEINE ANHYDROUS) CODEINE PHOSPHATE 30 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM
CROSPOVIDONE
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POVIDONE
STARCH, CORN
STEARIC ACID
Product Characteristics
Color white Score no score
Shape ROUND Size 11mm
Flavor Imprint Code IP33;3
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:67046-908-30 30 TABLET in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040779 05/29/2008
Labeler — Contract Pharmacy Services-PA (945429777)
Establishment
Name Address ID/FEI Operations
Coupler Enterprises 945429777 repack (67046-908)

Revised: 08/2017 Contract Pharmacy Services-PA

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