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.
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
LOT H18401501CEXP 08/2015
| 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 || |
|# ||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.
|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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