"Nov. 2, 2012 -- Safety steps taken in the wake of the fungal meningitis outbreak have worsened drug shortages, raising questions about whether the U.S. must choose between the safety and the availability of crucial medicines.
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|
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.
TYLENOL® with Codeine (acetaminophen and codeine phosphate) tablets are white, round, flat-faced, beveled edged tablet imprinted “McNEIL” on one side and “TYLENOL CODEINE” and either “3” or “4” on the other side and are supplied as follows: No. 3 - NDC 0045-0513-60 bottles of 100, NDC 0045-0513-80 bottles of 1000, No. 4 - NDC 0045-0515-60 bottles of 100, NDC 0045-0515-70 bottles of 500.
Store TYLENOL® with Codeine (acetaminophen and codeine) tablets at 20° to 25°C (68° to 77°F). (See USP Controlled Room Temperature.) Dispense in tight, light-resistant container as defined in the official compendium.
Manufactured by: JOLLC, Gurabo, Puerto Rico 00778. Distributed by: Omp Division, Ortho-Mcneil Pharmaceutical, Inc. Raritan, New Jersey 08869. Revised January 2008.
Last reviewed on RxList: 11/22/2010
This monograph has been modified to include the generic and brand name in many instances.
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