MEDICATION GUIDE

Hydrocodone Bitartrate and Acetaminophen Tablets, USP CII

HIGH-droe-KOE-dohnby-TAR-trate/ass-eet-ah-MEE-noe-fen

Hydrocodone Bitartrate and Acetaminophen Tablets are:

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A strong prescription pain medicine that contains an opioid (narcotic) that is used for the management of relief of moderate to moderately severe pain, pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate or when non-opioid pain medicines do not treat your pain well enough or you cannot tolerate them.

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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 Hydrocodone Bitartrate and Acetaminophen Tablets:

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Get emergency help right away if you take too much hydrocodone bitartrate and acetaminophen tablets (overdose). When you first start taking hydrocodone bitartrate and acetaminophen 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. 

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Taking hydrocodone bitartrate and acetaminophen tablets 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.

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Never give anyone else your hydrocodone bitartrate and acetaminophen tablets. They could die from taking it. Store hydrocodone bitartrate and acetaminophen tablets away from children and in a safe place to prevent stealing or abuse. Selling or giving away hydrocodone bitartrate and acetaminophen tablets is against the law.

Do not take Hydrocodone Bitartrate and Acetaminophen Tablets if you have:

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acute or severe bronchial asthma, trouble breathing, or other lung problems. 

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a bowel blockage or have narrowing of the stomach or intestines.

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significant respiratory depression 

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severe impairment of hepatic or renal function, hypothyroidism, Addison’s disease, prostatic hypertrophy or urethral stricture

Before  taking Hydrocodone Bitartrate and Acetaminophen Tablets, tell your healthcareprovider 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:

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pregnant or planning to become pregnant. Prolonged use of hydrocodone bitartrate and acetaminophen tablets during pregnancy can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated. 

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breastfeeding. Hydrocodone bitartrate and acetaminophen tablets passes into breast milk and may harm your baby.

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taking prescription or over-the-counter medicines, vitamins, or herbal supplements. Taking hydrocodone bitartrate and acetaminophen tablets with certain other medicines can cause serious side effects that could lead to death.

Whentaking Hydrocodone Bitartrate and Acetaminophen Tablets:     

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Do not change your dose. Take hydrocodone bitartrate and acetaminophen tablets exactly as prescribed by your healthcare provider. 

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The usual adult dosage is one tablet every four to six hours as needed for pain. The total daily dosage should not exceed 6 tablets. Do not take more than your prescribed dose. If you miss a dose, take your next dose at your usual time. 

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Call your healthcare provider if the dose you are taking does not control your pain.

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If you have been taking hydrocodone bitartrate and acetaminophen tablets regularly, do not stop taking hydrocodone bitartrate and acetaminophen tablets without talking to your healthcare provider.

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After you stop taking hydrocodone bitartrate and acetaminophen tablets, contact local state professional licensing board or state controlled substances authority for information on how to prevent and detect abuse or diversion of this product. 

While  taking Hydrocodone Bitartrate and Acetaminophen Tablets DO NOT:

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Drive or operate heavy machinery, until you know how hydrocodone bitartrate and acetaminophen tablets affects you. Hydrocodone bitartrate and acetaminophen tablets can make you sleepy, dizzy, or lightheaded. 

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Drink alcohol or use prescription or over-the-counter medicines that contain alcohol. Using products containing alcohol during treatment with hydrocodone bitartrate and acetaminophen tablets may cause you to overdose and die.

The  possible side effects of hydrocodone Bitartrate and Acetaminophen Tablets:

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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:

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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.

General Information about Hydrocodone Bitartrate and Acetaminophen Tablets

Medicinesare sometimes prescribed for purposes other than those listed in a MedicationGuide. Do not use hydrocodonebitartrate and acetaminophen tablets for a conditionfor which it was not prescribed. Do not give hydrocodone bitartrate andacetaminophen tablets to other people even if theyhave the same condition, they may harm them.

These are notall the possible side effects of hydrocodone bitartrate and acetaminophentablets. Call your doctor for medical advice about side effects. You may alsorequest medical information or to report suspected adverse reactions, contactAurobindo Pharma USA, Inc. at 1-866-850-2876 or FDA at 1-800-FDA-1088. Formore information go to dailymed.nlm.nih.gov

What are the ingredients in Hydrocodone Bitartrate andAcetaminophen Tablets?

Active Ingredients: hydrocodone bitartrate and acetaminophen

Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium,crospovidone, magnesium stearate, microcrystalline cellulose, povidone,pregelatinized starch and stearic acid.

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

Manufacturedby:
AurolifePharma LLC
Dayton, NJ08810

Manufacturedfor:
AurobindoPharma USA, Inc.
Dayton, NJ 08810 

Repackaged by:
Proficient Rx LP.
Thousand Oaks, CA 91320 

Revised:09/2016