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Roxicet

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Roxicet

ROXICET™
(oxycodone 5 mg and acetaminophen 325 mg) Tablets, USP
(oxycodone 5 mg and acetaminophen 325 mg) Oral Solution per 5 mL

DRUG DESCRIPTION

Each tablet for oral administration contains:

  Oxycodone Hydrochloride . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 mg+  
(+5 mg Oxycodone Hydrochloride is equivalent to 4.4815 mg Oxycodone) 
 Acetaminophen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 325 mg

Each 5 mL of oral solution for oral administration contains:

  Oxycodone Hydrochloride . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 mg+ 
 (+5 mg Oxycodone Hydrochloride is equivalent to 4.4815 mg Oxycodone) 
 Acetaminophen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 325 mg 
 Alcohol . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0.4%

Inactive Ingredients

The tablets contain colloidal silicon dioxide, croscarmellose sodium, microcrystalline cellulose and stearic acid.

The solution contains alcohol (0.4%), citric acid, disodium edetate, FD&C Red #40, flavors, fructose, polyethylene glycol, potassium sorbate, sodium saccharin and water.

ROXICET™ (oxycodone and acetaminophen ) contains oxycodone, 14-hydroxydihydrocodeinone, a semisynthetic opioid analgesic which occurs as a white, odorless, crystalline powder having a saline, bitter taste. The molecular formula for oxycodone hydrochloride is C18H21NO4 • HCl and the molecular weight is 351.83. It is derived from the opium alkaloid, thebaine, and may be represented by the following structural formula:

Oxycodone hydrochloride  Structural Formula Illustration

ROXICET™ (oxycodone and acetaminophen ) contains acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder, possessing a slightly bitter taste. The molecular formula for acetaminophen is C8H9NO2 and then molecular weight is 151.17. It may be represented by the following structural formula:

Acetaminophen  Structural Formula Illustration

What are the possible side effects of acetaminophen and oxycodone?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • shallow breathing, slow heartbeat;
  • feeling light-headed, fainting;
  • confusion, unusual thoughts or behavior;
  • seizure (convulsions);
  • problems with urination; or
  • nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or...

Read All Potential Side Effects and See Pictures of Roxicet »

Last reviewed on RxList: 6/19/2009
This monograph has been modified to include the generic and brand name in many instances.

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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