29 November 1985
COMMERCIAL ITEM DESCRIPTION
CHLORPHENIRAMINE MALEATE, ACETAMINOPHEN,
AND PHENYLPROPANOLAMINE HYDROCHLORIDE TABLETS
The General Services Administration has authorized the use of this commercial item description.
This commercial item description covers Chloropheniramine Maleate, Acetaminophen, and Phenylpropanolamine Hydrochloride Tablets for use as a Decongestant combination (antihistamine, decongestant, analgesic combination).
Shall be Chlorpheniramine Maleate† Acetaminophen, and Phenylpropanolamine Hydrochloride Tablets.
Shall contain 325 mg Acetaminophen, 12.5 my of Phenylpropanolamine Hydrochloride and 2 mg of Chlorpheniramine Maleate per tablet within the designated assay limits for the tablets.
Shall contain not less than 95 percent and not more than 105 percent of the required amount of Acetaminophen and not less than 90.0 percent and not more than 110.0 percent of the required amount of Phenylpropanolamine Hydrochloride and not less than 90.0 percent and not more than 115.0 percent of the required amount of† Chlorpheniramine Maleate when assayed by a suitable, accurate, and reproducible method.
The Acetaminophen, Chlorpheniramine Maleate and Phenylpropanolamine Hydrochloride in the finished tablet shall be identified by a suitable, accurate, and reproducible method.
The tablets shall disintegrate in not more than 30 minutes when determined by the USP method for Plain Coated Tablets.
Not less than 20 months of the expiration dating period shall remain at time of delivery to the Government.
Workmanship. Tablets shall be free from defects which detract from their appearance or impair their serviceability.
Unit. Package (PG). Shall be supplied 2 tablets in a commercially available packet. One package containing 100 packets, as specified, constitutes one unit.
Contractor certification. The contractor shall certify and maintain substantiating evidence that the product offered meets the salient characteristics of this Commercial Item Description, and that the product conforms to the producersí own drawings, specifications, standards, and quality assurance practices. The government reserves the right to require proof of such conformance prior to first delivery and thereafter as may be otherwise provided for under the provisions of the contract.
DISTRIBUTION STATEMENT A. Approved for public release; distribution is unlimited.
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