MEDICATION GUIDE

NORCO® (nor koe’)
Hydrocodone Bitartrate and Acetaminophen Tablets, USP, CII

NORCO® 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 NORCO®: 

• Get emergency help right away if you take too much NORCO® (overdose). When you first start taking NORCO® 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. 
  
• Never give anyone else your NORCO® tablets. They could die from taking it. Store NORCO® away from children and in a safe place to prevent stealing or abuse. Selling or giving away NORCO® tablets is against the law.

 Do not take NORCO® if you have: 

• severe asthma, trouble breathing, or other lung problems. 
  
• a bowel blockage or have narrowing of the stomach or intestines. 
  
• signs or allergy such as a rash. 
  
• are allergic to any of its ingredients. 

Before taking NORCO®, 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 NORCO® during pregnancy can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated. 
  
• breastfeeding. NORCO® passes into breast milk and may harm your baby. 
  
• taking prescription or over-the-counter medicines, vitamins, or herbal supplements. Taking NORCO® with certain other medicines can cause serious side effects that could lead to death. 

When taking NORCO®:

• Do not change your dose. Take NORCO® exactly as prescribed by your healthcare provider. 
  
• Take your prescribed dose every four to six hours at the same time every day. 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 NORCO® regularly, do not stop taking NORCO® without talking to your healthcare provider. 
  
• After you stop taking NORCO® tablets, flush any unused tablets down the toilet. 

While taking NORCO® DO NOT:

• Drive or operate heavy machinery, until you know how NORCO® affects you. NORCO® 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 NORCO® may cause you to overdose and die.

The possible side effects of NORCO®: 

• 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 NORCO®. 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

For more information call Actavis at 1-800-272-5525.

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

Manufactured by:
Warner Chilcott Company, LLC
Manati, Puerto Rico 00674

Distributed by:
Actavis Pharma, Inc.
Parsippany, NJ 07054 USA

Revised:  April 2016