Cold, cough, allergy, bronchodilator, and antiasthmatic drug products for over-the-counter human use; final rule for over-the-counter antitussive drug products; technical amendment. Final rule, technical amendment.
The Food and Drug Administration (FDA) is amending its regulations (exemption for certain drugs limited by new-drug applications to prescription sale, and warning and caution statements required by regulations for drugs) by removing the entries for carbetapentane citrate. This action is associated with FDA's determination that carbetapentane citrate has not been shown to be effective at the over-the-counter (OTC) doses stated in the exempting regulation. FDA made this determination in 1987 as part of its ongoing review of OTC drug products.
D000996:Antitussive Agents / Q000627:therapeutic use; D003257:Consumer Product Safety; D003517:Cyclopentanes / Q000627:therapeutic use; D004348:Drug Labeling / Q000331:legislation & jurisprudence*; D006801:Humans; D004366:Nonprescription Drugs; D014481:United States; D014486:United States Food and Drug Administration
D000996:Antitussive Agents; D003517:Cyclopentanes; D004366:Nonprescription Drugs