federal_register: 94-8511
Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API
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| document_number | title | type | abstract | publication_date | pub_year | pub_month | html_url | pdf_url | agency_names | agency_ids | excerpts | regulation_id_numbers |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 94-8511 | Antiemetic Drug Products for Over-The-Counter Human Use; Amendment of Final Monograph | Uncategorized Document | The Food and Drug Administration (FDA) is issuing a final rule amending the final monograph for over-the-counter (OTC) antiemetic drug products to revise a required warning and to add a similar warning for antiemetic drug products labeled for use only for children under 12 years of age. This final rule will ensure that warnings for ingredients contained in OTC antiemetic drug products are the same as those required for related ingredients used in other OTC drug products (e.g., antihistamines, antitussives, and nighttime sleep-aids). This final rule is part of the ongoing review of OTC drug products conducted by FDA. | 1994-04-11 | 1994 | 4 | https://www.federalregister.gov/documents/1994/04/11/94-8511/antiemetic-drug-products-for-over-the-counter-human-use-amendment-of-final-monograph | Health and Human Services Department; Food and Drug Administration | 221,199 | The Food and Drug Administration (FDA) is issuing a final rule amending the final monograph for over-the-counter (OTC) antiemetic drug products to revise a required warning and to add a similar warning for antiemetic drug products labeled for use only... |