ACETAMINOPHEN AND CODEINE- acetaminophen and codeine 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:

NuCare Pharmaceuticals, Inc.

INN (International Name):

ACETAMINOPHEN

Composition:

ACETAMINOPHEN 300 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Acetaminophen and Codeine Phosphate Tablets, USP are indicated for the relief of mild to moderately severe pain. Codeine-containing products are contraindicated for post-operative pain management in children who have undergone tonsillectomy and/or adenoidectomy. Acetaminophen and Codeine Phosphate Tablets should not be administered to patients who have previously exhibited hypersensitivity to codeine or acetaminophen. Acetaminophen and Codeine Phosphate Tablets are classified as a Schedule III controlled substance. 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:

Acetaminophen and Codeine Phosphate Tablets, USP 300 mg /30 mg are white, round, flat, beveled edged tablets debossed “IP 33” on obverse and “3” on reverse. They are available as follows: Bottles of 15: NDC 66267-001-15 Bottles of 20: NDC 66267-001-20 Bottles of 24: NDC 66267-001-24 Bottles of 30: NDC 66267-001-30 Bottles of 60: NDC 66267-001-60 Store Acetaminophen and Codeine Phosphate Tablets, USP 300 mg/30 mg 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. Questions or Comments? Call 1-877-835-5472 Monday through Friday 9AM-5PM EST. Repackaged by: NuCare Pharmaceuticals, Inc. Orange, CA 92867 Manufactured by: Amneal Pharmaceuticals Hauppauge, NY 11788 Rev. 12-2015-00

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ACETAMINOPHEN AND CODEINE- ACETAMINOPHEN AND CODEINE TABLET
NUCARE PHARMACEUTICALS, INC.
----------
ACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS, USP 300MG/30MG
CIII
RX ONLY
PRESCRIBING INFORMATION BOXED WARNING
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.
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.
DESCRIPTION
Each tablet contains:
Acetaminophen,
USP……………………………………………………..300
mg
Codeine Phosphate,
USP…………………………………………………...30 mg
(Warning: May be habit forming)
Inactive ingredients: croscarmellose sodium, crospovidone, lactose
monohydrate, magnesium stearate,
microcrystalline cellulose, povidone, pregelatinized starch and
stearic acid.
Acetaminophen and codeine is supplied in tablet form for oral
administration.
Acetaminophen, 4'-hydroxyacetanlllde, IS 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-l7-methylmorphinan-6α-ol
phosphate (1:1)
(salt) hemihydrate, a white crystalline powder, is a narcotic
analgesic and antitussive. It has the
following structural formula:
CLINICAL PHARMACOLOGY
Acetaminophen and Codeine Phosphate Tablets combines the analgesic
effects of a centrally acting
analgesic, codeine, with a peripherally acting analgesic,
acetaminophen.
PHARMACOKINETICS
The behavior on the individual components is described below.
Codeine
Codeine is rapidly abs