ACETAMINOPHEN with CODEINE (Page 3 of 3)

DOSAGE AND ADMINISTRATION

Dosage should be adjusted according to severity of pain and response of the patient.
Take (1 — 2) tablets orally every 6-8 hours as needed.
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 30, 50, 60, 90, 100, 120, 180, 500 and 1000.

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].

Acetaminophen and Codeine Phosphate Product Label

Acetaminophen/codeine 300/30mg tablets CIII
For indications, dosage, precautions, etc. see package insert.
Store at controlled room temperature 20-25° C (68-77° F.)
Do not use if foil wrap and seal are damaged
For questions call: 1-800-541-6315
Lot # NDC # Mft:
Packaged by PharmPak RX Only
Lot # L04401501C Exp. 12/31/2015 Qty: 1 tablet
ACETAMIN W/CODEINE
300/30G TABLETS
5434801501
LOT H18401501CEXP 08/2015

PharmPak 015 Label
(click image for full-size original)
PharmPak 015 1 Label
(click image for full-size original)
ACETAMINOPHEN WITH CODEINE acetaminophen, codeine phosphate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54348-015
Route of Administration ORAL DEA Schedule CIII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CODEINE PHOSPHATE (CODEINE ANHYDROUS) CODEINE PHOSPHATE 30 mg
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 300 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 (WHITE) Score 2 pieces
Shape ROUND (ROUND) Size 10mm
Flavor Imprint Code 2064;V;3
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54348-015-01 1 BLISTER PACK (BLISTER PACK) in 1 BOX contains a BLISTER PACK
1 1 TABLET (TABLET) in 1 BLISTER PACK This package is contained within the BOX (54348-015-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA089805 12/31/2013
Labeler — PharmPak, Inc. (175493840)
Registrant — PharmPak, Inc. (175493840)
Establishment
Name Address ID/FEI Operations
PharmPak, Inc. 175493840 relabel (54348-015), repack (54348-015)

Revised: 01/2015 PharmPak, Inc.

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