Acetaminophen and Codeine (Page 3 of 3)
Toxic Doses (for adults):
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
15 mg to 60 mg
300 mg to 1000 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.
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].
Huntsville, AL 35811
Marketed/ Packaged by:
Blenheim Pharmacal, Inc.
North Blenheim, NY 12131, (USA)
Package/Label Display Panel — 300mg/ 30mg 20s
Bottle Label 10544-100-20
| ACETAMINOPHEN AND CODEINE |
acetaminophen and codeine phosphate tablet
|Labeler — Blenheim Pharmacal, Inc. (171434587)|
|Registrant — Blenheim Pharmacal, Inc. (171434587)|
|Blenheim Pharmacal, Inc.||171434587||RELABEL (10544-100), REPACK (10544-100)|
Revised: 12/2013 Blenheim Pharmacal, Inc.
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