ACETAMINOPHEN AND CODEINE PHOSPHATE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D), CODEINE PHOSPHATE (UNII: GSL05Y1MN6) (CODEINE ANHYDROUS - UNII:UX6OWY2V7J)

Available from:

Direct RX

INN (International Name):

ACETAMINOPHEN

Composition:

ACETAMINOPHEN 300 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

- Acetaminophen and codeine phosphate tablets are indicated for the relief of mild to moderately severe pain. Acetaminophen and codeine phosphate tablets are indicated for the relief of mild to moderately severe pain. - Codeine-containing products are contraindicated for postoperative pain management in children who have undergone tonsillectomy and/or adenoidectomy. This product should not be administered to patients who have previously exhibited hypersensitivity to codeine or acetaminophen. Codeine-containing products are contraindicated for postoperative pain management in children who have undergone tonsillectomy and/or adenoidectomy. This product should not be administered to patients who have previously exhibited hypersensitivity to codeine or acetaminophen. - Controlled Substance Acetaminophen and codeine phosphate tablets are classified as a Schedule III controlled substance. Abuse and Dependence Codeine can produce drug dependence of the morphine type and, therefore, has the potential for being

Product summary:

Acetaminophen and codeine phosphate tablets USP (white, round, unscored): List No. 0050, acetaminophen 300 mg and codeine phosphate 15 mg, debossed "2" on one side and "TV"-"50" on the other side of tablet is available in bottles of 100 tablets. List No. 0150, acetaminophen 300 mg and codeine phosphate 30 mg, debossed "3" on one side and "TV"- "150" on the other side of tablet is available in bottles of 100 and 1000 tablets. List No. 0350, acetaminophen 300 mg and codeine phosphate 60 mg, debossed "4" on one side and "93"- "350" on the other side of tablet is available in bottles of 100, 500, and 1000 tablets. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from moisture. PROTECT FROM LIGHT Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. TEVA PHARMACEUTICALS USA Sellersville, PA 18960 Rev. AH 10/2013

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ACETAMINOPHEN AND CODEINE PHOSPHATE- ACETAMINOPHEN AND CODEINE
PHOSPHATE TABLET
DIRECT RX
----------
ACETAMINOPHEN AND CODEINE PHOSPHATE
BOXED WARNING
BOXED WARNING
Hepatotoxicity
Acetaminophen has been associated with cases of acute liver failure,
at times resulting in liver
transplant and death. Most of the cases of liver injury are associated
with the use of
acetaminophen at doses that exceed 4000 milligrams per day, and often
involve more than one
acetaminophen-containing product.
WARNING: Death Related to Ultra-Rapid Metabolism of Codeine to
Morphine
Respiratory depression and death have occurred in children who
received codeine following
tonsillectomy and/or adenoidectomy and had evidence of being
ultra-rapid metabolizers of
codeine due to a CYP2D6 polymorphism.
Close
DES CRIPTION
Acetaminophen and 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:
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:
Each tablet contains:
acetaminophen...........................300 mg
codeine phosphate.......................15 mg
(Warning: May be habit forming)
OR
acetaminophen...........................300 mg
codeine phosphate....................... 30 mg
(Warning: May be habit forming)
OR
acetaminophen...........................300 mg
codeine phosphate....................... 60 mg
(Warning: May be habit forming)
In addition, each tablet contains the following inactive ingredients:
corn starch, colloidal silicon
dioxide, croscarmellose sodium, magnesium stearate, and
microcrystalline cellulose. The 300
mg/60 mg strength tablets also contain crospovidone, povidone,
pregelatinized starch, and stearic
acid.
CLINICAL PHARMACOLOGY
This product combines the a