A-A-54111
16 March 1990
COMMERCIAL ITEM DESCRIPTION
CHLORPHENIRAMINE MALEATE TABLETS, MODIFIED
The General Services Administration has authorized the use of this Commercial Item Description as a replacement for Military Specification MIL-C-37284A which is cancelled.
Salient characteristics:
Shall be Chlorpheniramine Maleate Tablets, Modified, Timed.
Shall be in accordance with the requirements of the FDA.
Shall be coated, repeat-action release tablet containing 8 mg of Chlorpheniramine Maleate per tablet within the applicable assay limits for the tablets.
Shall assay to contain not less than 90.0 percent and not more than 110.0 percent of the required amount of Chlorpheniramine Maleate per tablet when assayed by a suitable, accurate and reproducible method.
Shall release half the active ingredient for rapid absorption and the remainder 4 to 6 hours later when determined by a suitable accurate and reproducible method.
All ingredients shall be of a pharmaceutical grade.
Each tablet shall be marked/embossed with a product identification code to identify the active ingredient(s), strength, and manufacturer. The materials used in marking/embossing the dosage forms shall be acceptable to the FDA. The actual code used for the product shall be left to the discretion of the supplier.
Workmanship. The tablets shall be free from defects which detract from their appearance or impair their serviceability.
Unit. Bottle (BT). One bottle containing 1000 tablets, as specified, constitutes one unit.
DISTRIBUTION STATEMENT A. Approved for public release; distribution is unlimited.
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