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Labeling of diphenhydramine-containing drug products for over-the-counter human use. Final rule.
Fed Regist. 2002 Dec 02; 67(235):72555-9.FR

Abstract

The Food and Drug Administration (FDA) is issuing a final rule amending the final monographs for over-the-counter (OTC) antiemetic, antihistamine, antitussive, and nighttime sleep-aid drug products to add a warning statement for oral products containing diphenhydramine citrate or diphenhydramine hydrochloride. The warning advises consumers not to use oral OTC diphenhydramine products with any other product containing diphenhydramine, including products used topically. This final rule also includes the agency's conclusions on additional warning statements and a direction statement for OTC external analgesic drug products containing diphenhydramine hydrochloride. These conclusions will be incorporated into the final monograph for OTC external analgesic drug products in a future issue of the Federal Register. FDA is issuing this final rule after considering public comments on the agency's proposed regulation and all new data and information on drug products containing diphenhydramine that have come to the agency's attention

Authors

No affiliation info available

Pub Type(s)

Journal Article

Language

eng

PubMed ID

12474879

Citation

Food and Drug Administration, HHS. "Labeling of Diphenhydramine-containing Drug Products for Over-the-counter Human Use. Final Rule." Federal Register, vol. 67, no. 235, 2002, pp. 72555-9.
Food and Drug Administration, HHS. Labeling of diphenhydramine-containing drug products for over-the-counter human use. Final rule. Fed Regist. 2002;67(235):72555-9.
Food and Drug Administration, HHS. (2002). Labeling of diphenhydramine-containing drug products for over-the-counter human use. Final rule. Federal Register, 67(235), 72555-9.
Food and Drug Administration, HHS. Labeling of Diphenhydramine-containing Drug Products for Over-the-counter Human Use. Final Rule. Fed Regist. 2002 Dec 2;67(235):72555-9. PubMed PMID: 12474879.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Labeling of diphenhydramine-containing drug products for over-the-counter human use. Final rule. A1 - ,, PY - 2002/12/12/pubmed PY - 2002/12/27/medline PY - 2002/12/12/entrez SP - 72555 EP - 9 JF - Federal register JO - Fed Regist VL - 67 IS - 235 N2 - The Food and Drug Administration (FDA) is issuing a final rule amending the final monographs for over-the-counter (OTC) antiemetic, antihistamine, antitussive, and nighttime sleep-aid drug products to add a warning statement for oral products containing diphenhydramine citrate or diphenhydramine hydrochloride. The warning advises consumers not to use oral OTC diphenhydramine products with any other product containing diphenhydramine, including products used topically. This final rule also includes the agency's conclusions on additional warning statements and a direction statement for OTC external analgesic drug products containing diphenhydramine hydrochloride. These conclusions will be incorporated into the final monograph for OTC external analgesic drug products in a future issue of the Federal Register. FDA is issuing this final rule after considering public comments on the agency's proposed regulation and all new data and information on drug products containing diphenhydramine that have come to the agency's attention SN - 0097-6326 UR - https://www.unboundmedicine.com/medline/citation/12474879/Labeling_of_diphenhydramine_containing_drug_products_for_over_the_counter_human_use__Final_rule_ L2 - https://www.govinfo.gov/content/pkg/FR-2002-12-06/pdf/02-30641.pdf DB - PRIME DP - Unbound Medicine ER -