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Tylenol-Codeine

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Tylenol-Codeine

TYLENOL® with Codeine
(acetaminophen with codeine phosphate) Tablets, USP

DRUG DESCRIPTION

TYLENOL® with Codeine is supplied in tablet form for oral administration.

Acetaminophen, 4'-hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula:

Acetaminophen Structural Formula Illustration

C8H9NO2   M.W. 151.16

Codeine phosphate, 7,8-didehydro-4, 5α-epoxy-3-methoxy-17-methylmorphinan-6α-ol phosphate (1:1) (salt) hemihydrate, a white crystalline powder, is a narcotic analgesic and antitussive. It has the following structural formula:

Codeine phosphate Structural Formula Illustration

C18H21NO3•H3PO4•1/2 H2O   M.W. 406.37

Each tablet contains:

Acetaminophen. . . . . . . . . . . . . . . . . . . 300 mg
No. 3 Codeine Phosphate . . . . . . . . . . . 30 mg
(Warning: May be habit forming)

Acetaminophen. . . . . . . . . . . . . . . . . . . 300 mg
No. 4 Codeine Phosphate . . . . . . . . . . . 60 mg
(Warning: May be habit forming)

In addition, each tablet contains the following inactive ingredients:

TYLENOL® with Codeine (acetaminophen and codeine) No. 3 contains powdered cellulose, magnesium stearate, sodium metabisulfite†, pregelatinized starch (corn), and modified starch (corn).

TYLENOL® with Codeine (acetaminophen and codeine) No. 4 contains powdered cellulose, magnesium stearate, sodium metabisulfite†, pregelatinized starch (corn), and corn starch.

†See WARNINGS

What are the possible side effects of acetaminophen and codeine?

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

Read All Potential Side Effects and See Pictures of Tylenol-Codeine »

What are the precautions when taking acetaminophen and codeine (Tylenol-Codeine)?

See also Warning section.

Before taking this product, tell your doctor or pharmacist if you are allergic to acetaminophen or codeine; or to other narcotic pain medications (such as morphine); or if you have any other allergies. This product may contain inactive ingredients (such as metabisulfite), 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...

Read All Potential Precautions of Tylenol-Codeine »

Last reviewed on RxList: 11/22/2010
This monograph has been modified to include the generic and brand name in many instances.

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Tylenol-Codeine - User Reviews

Tylenol-Codeine 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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