ACETAMINOPHEN AND CODEINE PHOSPHATE tablet

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

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

Verfügbar ab:

EPM Packaging Inc

INN (Internationale Bezeichnung):

ACETAMINOPHEN

Zusammensetzung:

ACETAMINOPHEN 300 mg

Verabreichungsweg:

ORAL

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

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.

Produktbesonderheiten:

HOW SUPPLIED Acetaminophen and codeine phosphate tablets USP (white, round, unscored): 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 (NDC 0093-0050-01) 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 (NDC 0093-0150-01) and 1000 (NDC 0093-0150-10) 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 (NDC 0093-0350-01), 500 (NDC 0093-0350-05), and 1000 (NDC 0093-0350-10) 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. Distributed By: TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454 Rev. AI 8/2015

Berechtigungsstatus:

Abbreviated New Drug Application

Fachinformation

ACETAMINOPHEN AND CODEINE PHOSPHATE- ACETAMINOPHEN AND CODEINE
PHOSPHATE TABLET
EPM PACKAGING INC
----------
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 Metabolis m 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.
ACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS, USP CIII
Rx only
Acetaminophen and codeine are supplied in tablet form for oral
administration.
Acetaminophen, USP, 4'-hydroxyacetanilide, a slightly bitter, white,
odorless, crystalline powder, is a
non-opiate, non-salicylate analgesic and antipyretic. It has the
following structural formula:
C H NO M.W. 151.16
Codeine phosphate, USP,
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:
8 9 2
C H NO •H PO •1/2H O M.W. 406.37
Each tablet contains:
acetaminophen, USP...........................300 mg
codeine phosphate, USP.......................15 mg
(Warning: May be habit forming)
OR
acetaminophen, USP...........................300 mg
codeine phosphate, USP....................... 30 mg
(Warning: May be habit forming)
OR
acetaminophen, USP...........................300 mg
codeine phosphate, USP....................... 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,