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Roxicet

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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); or
  • nausea, stomach pain, loss of appetite, itching, dark urine, clay-colored stools, jaundice (yellowing of the...

Read All Potential Side Effects and See Pictures of Roxicet »

What are the precautions when taking oxycodone and acetaminophen (Roxicet)?

Before taking this medication, tell your doctor or pharmacist if you are allergic to it; or to other narcotics (such as morphine, codeine); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: brain disorders (such as head injury, tumor, seizures), breathing problems (such as asthma, sleep apnea, chronic obstructive pulmonary disease-COPD), kidney disease, liver disease, mental/mood disorders (such as confusion, depression), personal or family history of regular use/abuse of drugs/alcohol, stomach/intestinal problems (such as blockage, constipation, diarrhea...

Read All Potential Precautions of Roxicet »

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

Roxicet - User Reviews

Roxicet User Reviews

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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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