Medication Guide

MEDICATION GUIDE

Acetaminophenand Codeine Phosphate Tablets, USP CIII

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Acetaminophen and Codeine PhosphateTablets 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 codeinephosphate 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 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 are against the law.

Do not take Acetaminophen and Codeine Phosphate Tablets ifyou 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 phosphatetablets, tell your healthcare providerif 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. acetaminophen and codeine phosphate passes into breast milk and 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 it down the toilet or dispose of in accordance with local state guidelines and/or regulations.

While taking acetaminophen and codeine phosphate tabletsDO NOT:

• Drive or operate heavy machinery, until you know how acetaminophen and codeine phosphate tablets affects 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 phosphatetablets:

• 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 allthe possible side effects of acetaminophen and codeine phosphate tablets. Callyour doctor for medical advice about side effects. You may also request medicalinformation or to report suspected adverse reactions, contact Aurobindo PharmaUSA, Inc. at 1-866-850-2876 or FDA at 1-800-FDA-1088. For more information go todailymed.nlm.nih.gov

What are the ingredients in Acetaminophen and CodeinePhosphate Tablets?

Active Ingredients: acetaminophen and codeine phosphate

Inactive ingredients:colloidal silicon dioxide, croscarmellose sodium,crospovidone, magnesium stearate, microcrystalline cellulose, povidone,pregelatinized starch, sodium lauryl sulfate, and stearicacid

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

Manufacturedby:

Aurolife Pharma LLC

Dayton, NJ 08810

Manufacturedfor:

Aurobindo Pharma USA, Inc.

Dayton, NJ 08810

Revised: 12/2016