PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN - propoxyphene napsylate and acetaminophen tablet, film coated
RedPharm Drug Inc.
----------
PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN TABLETS USP CIV
Rx only
Read this Medication Guide before you start taking propoxyphene napsylate and acetaminophen tablets USP 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 USP?
Propoxyphene napsylate and acetaminophen tablets USP 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 USP may happen when they are taken by themselves, or with alcohol or other medicines that can also decrease your breathing and make you very sleepy.
Take propoxyphene napsylate and acetaminophen tablets USP exactly as prescribed. Do not change your dose or stop taking propoxyphene napsylate and acetaminophen tablets USP without first talking to your doctor.
What are propoxyphene napsylate and acetaminophen tablets USP?
It is not known if propoxyphene napsylate and acetaminophen tablets USP are safe and effective in children under age 18.
Who should not take propoxyphene napsylate and acetaminophen tablets USP?
Do not take propoxyphene napsylate and acetaminophen tablets USP if you:
What should I tell my doctor before taking propoxyphene napsylate and acetaminophen tablets USP?
Before taking propoxyphen napsylate and acetaminophen tablets USP, tell your doctor:
Tell your doctor about all the medicines you take, including prescription, and non-prescription medicines, vitamins, and herbal supplements. Propoxyphene napsylate and acetaminophen tablets USP interact 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 USP?"
Do not take other medicines that contain acetaminophen while taking propoxyphene napsylate and acetaminophen tablets USP. See "What are the possible side effects of propoxyphene napsylate and acetaminophen tablets USP?"
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 USP?
See "What is the most important information I should know about propoxyphene napsylate and acetaminophen tablets USP?"
Signs and symptoms of an overdose of propoxyphene napsylate and acetaminophen tablets USP include:
What are the possible side effects of propoxyphene napsylate and acetaminophen tablets USP?
Propoxyphene napsylate and acetaminophen tablets USP can cause serious side effects, including:
See "What is the most important information I should know about propoxyphene napsylate and acetaminophen tablets USP?"
Tell your doctor if you have any of these withdrawal symptoms while you slowly stop taking propoxyphene napsylate and acetaminophen tablets USP. You may need to stop propoxyphene napsylate and acetaminophen tablets USP more slowly.
Common side effects of propoxyphene napsylate and acetaminophen tablets USP include:
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
You may also report side effects to TEVA USA, PHARMACOVIGILANCE at 1-888-838-2872, X6351.
How should I store propoxyphene napsylate and acetaminophen tablets USP?
Keep propoxyphene napsylate and acetaminophen tablets USP and all medicines out of the reach of children.
General information about propoxyphene napsylate and acetaminophen tablets USP
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use propoxyphene napsylate and acetaminophen tablets USP for a purpose for which they were not prescribed. Do not give propoxyphene napsylate and acetaminophen tablets USP 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 USP. 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 USP that is written for health professionals. For more information, call 1-888-838-2872, MEDICAL AFFAIRS.
What are the ingredients in propoxyphene napsylate and acetaminophen tablets USP?
Active ingredients: propoxyphene napsylate and acetaminophen
Propoxyphene napsylate and acetaminophen tablets, USP 100 mg/650 mg (PINK) contain the following inactive ingredients: colloidal silicon dioxide, D&C Red No. 27 aluminum lake, D&C Yellow No. 10 aluminum lake, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid, titanium dioxide, and crospovidone.
Propoxyphene napsylate and acetaminophen tablets, USP 100 mg/650 mg (WHITE) contain the following inactive ingredients: castor oil, colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, stearic acid, and crospovidone.
This Medication Guide has been approved by the U.S. Food and Drug Administration.
All brand names listed are the registered trademarks of their respective owners and are not trademarks of Teva Pharmaceuticals USA.
TEVA PHARMACEUTICALS USA
Sellersville, PA 18960
Iss. 10/2009