Medication Guide

Acetaminophen (a seet’ a min’ oh fen) and Codeine Phosphate (koe’ deen fos’ fate) Tablets, USP 300 mg/30 mg and 300 mg/60 mg, CIII

• Acetaminophen and Codeine Phosphate Tablets, USP 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, USP:

•Get emergency help or call 911 right away if you take too much Acetaminophen and Codeine Phosphate Tablets, USP (overdose).When you first start taking Acetaminophen and Codeine Phosphate Tablets, USP, 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. Talk to your healthcare provider about naloxone, a medicine for the emergency treatment of an opioid overdose.

•Taking acetaminophen and codeine phosphate tablets, USP 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, USP. They could die from taking it. Selling or giving away Acetaminophen and Codeine Phosphate Tablets, USP is against the law.

•Store Acetaminophen and Codeine Phosphate Tablets, USP 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, USP 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.
• told by your healthcare provider that you are a “rapid metabolizer” of certain medicines.
• Before taking Acetaminophen and Codeine Phosphate Tablets, USP, 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, opioid overdose, 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:
  1. pregnant or planning to become pregnant.Prolonged use of Acetaminophen and Codeine Phosphate Tablets, USP during pregnancy can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated.
  2. breastfeeding.Not recommended; may harm your baby.
  3. living in a household where there are small children or someone who has abused street or prescription drugs
• taking prescription or over-the-counter medicines, vitamins, or herbal supplements. Acetaminophen and Codeine Phosphate Tablets, USP with certain other medicines can cause serious side effects that could lead to death.
• When taking Acetaminophen and Codeine Phosphate Tablets, USP:
  1. Do not change your dose. Take Acetaminophen and Codeine Phosphate Tablets, USP exactly as prescribed by your healthcare provider. Use the lowest dose possible for the shortest time needed.
  2. 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.
  3. Call your healthcare provider if the dose you are taking does not control your pain.
  4. If you have been taking Acetaminophen and Codeine Phosphate Tablets, USP regularly, do not stop taking Acetaminophen and Codeine Phosphate Tablets, USP without talking to your healthcare provider.
  5. Dispose of expired, unwanted, or unused Acetaminophen and Codeine Phosphate Tablets, USP 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, USP 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, USP DO NOT:

• Drive or operate heavy machinery, until you know how Acetaminophen and Codeine Phosphate Tablets, USP affect you. Acetaminophen and Codeine Phosphate Tablets, USP 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, USP may cause you to overdose and die.

The possible side effects of Acetaminophen and Codeine Phosphate Tablets, USP:

• 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 or call 911 right away 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, USP. 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:

CorePharma LLC

Middlesex, NJ 08846 USA

Distributed by:

Sun Pharmaceutical Industries Inc.

Cranbury, NJ 08512

1. August 2020 FDA-07

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