22 November 1985
COMMERCIAL ITEM DESCRIPTION
CHLORPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE
HYDROCHLORIDE CAPSULES, SUSTAINED-RELEASE
The General Services Administration has authorized the use of this commercial item description.
The Commercial Item Description covers Chlorpheniramine Maleate and Pseudoephedrine Hydrochloride Capsules, Sustained-Release used as a sustained release antihistamine and decongestant.
Shall be sustained-release Chlorpheniramine Maleate and Pseudoephedrine Hydrochloride Capsules.
Shall contain 8 mg of Chlorpheniramine Maleate and 120 mg of Pseudoephedrine Hydrochloride per capsule when tested using a suitable, accurate and reproducible method.
Shall be labeled for a dosage of one capsule every 8 to 12 hours.
Not less than 32 months of the expiration dating period shall remain at time of delivery to the Government.
Workmanship. Capsules shall be free from defects which detract from their appearance or impair their serviceability.
Unit. Bottle (BT). One bottle containing 500 capsules, as specified, constitutes one unit
Contractor certification. The contractor shall certify that the product offered meets the salient characteristics of this description and 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.
Federal Food, Drug and Cosmetic Act. If the product covered by this document has been determined by the U. S. Food and Drug Administration to be under its jurisdiction, the offeror/contractor shall comply, and be responsible for compliance by its subcontractors/suppliers, with the requirements of the Federal Food, Drug and Cosmetic Act, as amended, and regulations promulgated thereunder. In addition, the offeror/contractor shall comply, and be responsible for compliance by its subcontractors/suppliers, with the requirements of all other applicable Federal, State, and local statutes, ordinances, and regulations.
DISTRIBUTION STATEMENT A. Approved for public release; distribution is unlimited.
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