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Laxative drug products for over-the-counter human use. Food and Drug Administration, HHS. Final rule.
Fed Regist. 1999 Jan 29; 64(19):4535-40.FR

Abstract

The Food and Drug Administration (FDA) is issuing a final rule establishing that the over-the-counter (OTC) stimulant laxative ingredients danthron and phenolphthalein are not generally recognized as safe and effective and are misbranded. FDA is issuing this final rule as part of its ongoing review of OTC drug products after considering data and information on the safety of danthron and phenolphthalein.

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MeSH

AnthraquinonesCarcinogenicity TestsCatharticsDrug ApprovalDrug LabelingHumansNonprescription DrugsPhenolphthaleinUnited StatesUnited States Food and Drug Administration

Pub Type(s)

Journal Article

Language

eng

PubMed ID

10557608

Citation

"Laxative Drug Products for Over-the-counter Human Use. Food and Drug Administration, HHS. Final Rule." Federal Register, vol. 64, no. 19, 1999, pp. 4535-40.
Laxative drug products for over-the-counter human use. Food and Drug Administration, HHS. Final rule. Fed Regist. 1999;64(19):4535-40.
(1999). Laxative drug products for over-the-counter human use. Food and Drug Administration, HHS. Final rule. Federal Register, 64(19), 4535-40.
Laxative Drug Products for Over-the-counter Human Use. Food and Drug Administration, HHS. Final Rule. Fed Regist. 1999 Jan 29;64(19):4535-40. PubMed PMID: 10557608.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Laxative drug products for over-the-counter human use. Food and Drug Administration, HHS. Final rule. PY - 1999/11/11/pubmed PY - 1999/11/11/medline PY - 1999/11/11/entrez SP - 4535 EP - 40 JF - Federal register JO - Fed Regist VL - 64 IS - 19 N2 - The Food and Drug Administration (FDA) is issuing a final rule establishing that the over-the-counter (OTC) stimulant laxative ingredients danthron and phenolphthalein are not generally recognized as safe and effective and are misbranded. FDA is issuing this final rule as part of its ongoing review of OTC drug products after considering data and information on the safety of danthron and phenolphthalein. SN - 0097-6326 UR - https://www.unboundmedicine.com/medline/citation/10557608/Laxative_drug_products_for_over_the_counter_human_use__Food_and_Drug_Administration_HHS__Final_rule_ L2 - https://www.govinfo.gov/content/pkg/FR-1999-01-29/pdf/99-1938.pdf DB - PRIME DP - Unbound Medicine ER -