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

Package/Label Display Panel -- 300mg/ 30mg 20s
(click image for full-size original)
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.

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