Acetaminophen and Codeine (Page 3 of 3)

Toxic Doses (for adults):

Acetaminophen:	toxic dose	10 g
Codeine:	toxic dose	240 mg

DOSAGE AND ADMINISTRATION

Dosage should be adjusted according to severity of pain and response of the patient. The usual adult dosage is:

	Single Doses (range)	Maximum 24 Hour Dose
Codeine Phosphate	15 mg to 60 mg	360 mg
Acetaminophen	300 mg to 1000 mg	4000 mg

The usual dose of codeine phosphate in children is 0.5 mg/kg.

Doses may be repeated up to every 4 hours.

The prescriber must determine the number of tablets per dose, and the maximum number of tablets per 24 hours based upon the above dosage guidance. This information should be conveyed in the prescription.

It should be kept in mind, however, that tolerance to codeine can develop with continued use and that the incidence of untoward effects is dose related. Adult doses of codeine higher than 60 mg fail to give commensurate relief of pain but merely prolong analgesia and are associated with an appreciably increased incidence of undesirable side effects. Equivalently high doses in children would have similar effects.

HOW SUPPLIED

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 10, 15 and 20.

Storage and Handling

Dispense in a tight, light resistant container as defined in the USP/NF.

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Manufactured for:
QUALITEST PHARMACEUTICALS
Huntsville, AL 35811

Marketed/ Packaged by:

Blenheim Pharmacal, Inc.
North Blenheim, NY 12131, (USA)

8182436
R11/07-R2

Package/Label Display Panel — 300mg/ 30mg 20s

Bottle Label 10544-100-20

ACETAMINOPHEN AND CODEINE acetaminophen and codeine phosphate tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:10544-100(NDC:0603-2338) Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 300 mg CODEINE PHOSPHATE (CODEINE ANHYDROUS) CODEINE PHOSPHATE 30 mg

Inactive Ingredients Ingredient Name Strength MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POVIDONES STARCH, CORN SODIUM METABISULFITE SODIUM STARCH GLYCOLATE TYPE A POTATO STEARIC ACID

Product Characteristics Color white Score 2 pieces Shape ROUND Size 10mm Flavor Imprint Code 2064;V;3 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:10544-100-10 10 TABLET in 1 BOTTLE None 2 NDC:10544-100-15 15 TABLET in 1 BOTTLE None 3 NDC:10544-100-20 20 TABLET in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA089805 11/11/2013

Labeler — Blenheim Pharmacal, Inc. (171434587)

Registrant — Blenheim Pharmacal, Inc. (171434587)

Establishment
Name	Address	ID/FEI	Operations
Blenheim Pharmacal, Inc.		171434587	RELABEL (10544-100), REPACK (10544-100)

Revised: 12/2013 Blenheim Pharmacal, Inc.