PROPOXYPHENE AND ACETAMINOPHEN - propoxyphene napsylate and acetaminophen tablet, film coated 
Keltman Pharmaceuticals Inc.

----------

Inform patients of the availability of a Medication Guide for propoxyphene napsylate and acetaminophen tablets that accompanies each prescription dispensed. Instruct patients to read the propoxyphene napsylate and acetaminophen tablets Medication Guide prior to using propoxyphene napsylate and acetaminophen tablets.

MEDICATION GUIDE

Read this Medication Guide before you start taking propoxyphene napsylate and acetaminophen tablets and each time you get a refill. There may be new information. This information does not take the place of talking to your doctor about your medical condition or your treatment.

What is the most important information I should know about propoxyphene napsylate and acetaminophen tablets?

Propoxyphene napsylate and acetaminophen tablets and other medicines that contain propoxyphene can cause serious side effects, including:

Overdoses by accident or on purpose (intentional overdose). Overdoses with propoxyphene napsylate and acetaminophen tablets may happen when it is taken by itself, or with alcohol or other medicines that can also decrease your breathing and make you very sleepy.

Take propoxyphene napsylate and acetaminophen tablets exactly as prescribed. Do not change your dose or stop taking propoxyphene napsylate and acetaminophen tablets without first talking to your doctor.

What is propoxyphene napsylate and acetaminophen tablets?

  • Propoxyphene napsylate and acetaminophen tablets is a federally controlled substance (C-IV) because it is a strong opioid pain medicine that can be abused by people who abuse prescription medicines or street drugs.
  • Prevent theft, misuse or abuse. Keep propoxyphene napsylate and acetaminophen tablets in a safe place to protect it from being stolen. Propoxyphene napsylate and acetaminophen tablets can be a target for people who misuse or abuse prescription medicines or street drugs.
  • Never give propoxyphene napsylate and acetaminophen tablets to anyone else, even if they have the same symptoms that you have. It may harm them or even cause death. Selling or giving away this medicine is against the law.
 

It is not known if propoxyphene napsylate and acetaminophen tablets is safe and effective in children under age 18.

Who should not take propoxyphene napsylate and acetaminophen tablets?

Do not take propoxyphene napsylate and acetaminophen tablets if you:

What should I tell my doctor before taking propoxyphene napsylate and acetaminophen tablets?

Before taking propoxyphene napsylate and acetaminophen tablets, tell your doctor:

Tell your doctor about all the medicines you take, including prescription, and nonprescription medicines, vitamins, and herbal supplements. Propoxyphene napsylate and acetaminophen tablets interacts with many medicines and may lead to serious side effects. The doses of certain medicines may need to be changed.

Especially tell your doctor if you take:
See "What is the most important information I should know about propoxyphene napsylate and acetaminophen tablets?"

Do not take other medicines that contain acetaminophen while taking propoxyphene napsylate and acetaminophen tablets. See "What are the possible side effects of propoxyphene napsylate and acetaminophen tablets?"

Ask your doctor or pharmacist if you are not sure if your medicine is one listed above.

Know the medicines you take. Keep a list of them to show to your doctor and pharmacist when you get a new medicine.

How should I take propoxyphene napsylate and acetaminophen tablets?
See "What is the most important information I should know about propoxyphene napsylate and acetaminophen tablets?"

Signs and symptoms of an overdose of propoxyphene napsylate and acetaminophen tablets include:

What are the possible side effects of propoxyphene napsylate and acetaminophen tablets? 
Propoxyphene napsylate and acetaminophen tablets can cause serious side effects, including:
See "What is the most important information I should know about propoxyphene napsylate and acetaminophen tablets?" 

Tell your doctor if you have any of these withdrawal symptoms while you slowly stop taking propoxyphene napsylate and acetaminophen tablets. You may need to stop propoxyphene napsylate and acetaminophen tablets more slowly.

Common side effects of propoxyphene napsylate and acetaminophen tablets include:

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store propoxyphene napsylate and acetaminophen tablets?

Keep propoxyphene napsylate and acetaminophen tablets and all medicines out of the reach of children.


General information about propoxyphene napsylate and acetaminophen tablets

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use propoxyphene napsylate and acetaminophen tablets for a purpose for which it was not prescribed. Do not give propoxyphene napsylate and acetaminophen tablets to others even if they have the same symptoms you have. It may harm them and is against the law. This Medication Guide summarizes the most important information about propoxyphene napsylate and acetaminophen tablets. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about propoxyphene napsylate and acetaminophen tablets that is written for health professionals.

What are the ingredients in propoxyphene napsylate and acetaminophen tablets?

Propoxyphene napsylate and acetaminophen tablets 50 mg/325 mg:

Active ingredients: propoxyphene napsylate and acetaminophen
Inactive ingredients: carnuba wax, D&C Yellow #10 Aluminum Lake, FD&C Red #40 Aluminum Lake, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, polysorbate 80, sodium starch glycolate and titanium dioxide.

Propoxyphene napsylate and acetaminophen tablets 100 mg/650 mg:

Active ingredients: propoxyphene napsylate and acetaminophen
Inactive ingredients: carnuba wax, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, polysorbate 80, sodium starch glycolate and titanium dioxide. The orange tablets also contain D&C Yellow #10 Aluminum Lake, FD&C Red #40 Aluminum Lake. The pink tablets also contain FD&C Red #40 Aluminum Lake.

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

Revised: 8/2010
Keltman Pharmaceuticals Inc.