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:

Quality Care Products LLC

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. 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 abused. Psychological dependence, physical dependence, and tolerance may develop upon repeated administration and it should be prescribed and administered with the same degree of caution appropriate to the use of other oral narcotic medications.

Product summary:

Each Acetaminophen and Codeine Phosphate Tablet USP 300 mg/15 mg tablet contains acetaminophen 300 mg and codeine phosphate 15 mg. It is available as a round, white to off-white tablet debossed with “2” on one side and an  on the other side. Each Acetaminophen and Codeine Phosphate Tablet USP 300 mg/30 mg tablet contains acetaminophen 300 mg and codeine phosphate 30 mg. It is available as a round, white to off-white tablet debossed with “3” on one side and an  on the other side. Each Acetaminophen and Codeine Phosphate Tablet USP 300 mg/60 mg tablet contains acetaminophen 300 mg and codeine phosphate 60 mg. It is available as a round, white to off-white tablet debossed with “4” on one side and an  on the other side. 49999-026-30 49999-026-60 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in tight, light-resistant container as defined in the USP. Mallinckrodt, the “M” brand mark, the Mallinckrodt Pharmaceuticals logo and  are trademarks of a Mallinckrodt company. © 2014 Mallinckrodt. Mallinckrodt Inc. Hazelwood, MO 63042 USA Rev 12/2014 Mallinckrodt™ Pharmaceuticals

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ACETAMINOPHEN AND CODEINE PHOSPHATE- ACETAMINOPHEN AND CODEINE
PHOSPHATE TABLET
QUALITY CARE PRODUCTS LLC
----------
ACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS USP
(300 MG/15 MG, 300 MG/30 MG, 300 MG/60 MG)
CIII
RX ONLY
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 (_SEE _WARNINGS).
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.
DESCRIPTION
Acetaminophen and codeine phosphate 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 Acetaminophen and Codeine Phosphate Tablet USP (300 mg/15 mg)
contains:
Acetaminophen USP . . . . . . . . . . . . . 300 mg
Codeine Phosphate USP . . . . . . . . . . . . . 15 mg
(Warning: May be habit forming)
Each Acetaminophen and Codeine Phosphate Tablet USP (300 mg/30 mg)
contains:
Acetaminophen USP . . . . . . . . . . . . . 300 mg
Codeine Phosphate USP . . . . . . . . . . . . . 30 mg
(Warning: May be habit forming)
Each Acetaminophen and Codeine Phosphate Tablet USP (300 mg/60 mg)
contains:
Acetaminophen USP . . . . . . . . . . . . . 300 mg
Codeine Phosphate USP . . . . . . . . . . . . . 60 mg
(Warning: May be habit forming)
In addition, each Acetam