ACETAMINOPHEN AND CODEINE PHOSPHATE tablet

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

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

Disponible depuis:

Apotheca, Inc.

DCI (Dénomination commune internationale):

ACETAMINOPHEN

Composition:

ACETAMINOPHEN 300 mg

Mode d'administration:

ORAL

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

Acetaminophen and codeine phosphate tablets are indicated for the relief of mild to moderately severe pain. 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

Descriptif du produit:

Acetaminophen and Codeine Phosphate Tablets 300 mg/30 mg are white, round, flat-faced, beveled edge, scored (bisect bar) tablets, debossed "2064" and "V" on one side and debossed "3" on the reverse side. They are supplied in bottles of 30, 50, 60, 90, 100, 120, 180, 500 and 1000. Acetaminophen and Codeine Phosphate Tablets 300 mg/60 mg are white, round, flat-faced, beveled edge, scored (bisect bar) tablets, debossed "2065" and "V" on one side and debossed "4" on the reverse side. They are supplied in bottles of 100, 500 and 1000.

Statut de autorisation:

Abbreviated New Drug Application

Résumé des caractéristiques du produit

ACETAMINOPHEN AND CODEINE PHOSPHATE- ACETAMINOPHEN AND CODEINE
PHOSPHATE TABLET
APOTHECA, INC.
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ACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS USP CIII RX ONLY
DESCRIPTION
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. (TEVA PHARMACEUTICALS).
In addition each tablet contains the following inactive ingredients:
magnesium stearate, microcrystalline
cellulose, povidone, pregelatinized corn starch, sodium metabisulfite,
sodium starch glycolate and
stearic acid. (VINTAGE PHARMACEUTICALS)
CLINICAL PHARMACOLOGY
This product combines the analgesic effects of a centrally acting
analgesic, codeine, with a
peripherally acting analgesic, acetaminophen.
PHARMACOKINETICS
The behavior of the individual components is described below.
CODEINE
Codeine is readily absorbed from the gastrointestinal tract. It is
rapidly distributed from the
intravascular spaces to the various body tissues, with