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U.S. Department of Health and Human Services

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Rulemaking History for OTC Food and Drink Overindulgence Drug Products

Pending Final Monograph (21 CFR part 357 subpart J):  
Miscellaneous Internal Drug Products for Over-the-Counter Human Use: Orally Administered Drug Products for Relief of Symptoms Associated with Overindulgence in Food and Drink for Over-the-Counter Human Use

OTC Food and Drink overindulgence Drug Products found on this page:


Food and Drink Overindulgence Drug Products: Original Active Ingredients and Labeling
Advance Notice Of Proposed Rulemaking Date FR Citation
Advance Notice of Proposed Rulemaking [PDF] 10/1/1982 47FR43540
    Correction [PDF] 12/10/1982 47FR55497
    Correction [PDF] 12/21/1982 47FR56871
    Extension of Comment Period [PDF] 1/4/1983 48FR270
Notice: Classifies "prevention of inebriation" claim as nonmonograph [PDF] 7/19/1983 48FR32872
Proposed Rule Date FR Citation
Tentative Final Monograph [PDF] 12/24/1991 56FR66742
    Correction [PDF] 3/4/1992 57FR7847

Food and Drink Overindulgence Drug Products: Internal Analgesics
Proposed Rule Date FR Citation
Proposed Rule: Amends 21 CFR part 343 to allow stimulant and internal analgesic combinations [PDF] 12/24/1991 56FR66762

Food and Drink Overindulgence Drug Products: Antacids
Proposed Rule Date FR Citation
Proposed Rule: Amends 21 CFR part 331 to allow overindulgence claims for antacids [PDF] 12/24/1991 56FR66754

Food and Drink Overindulgence Drug Products: Bismuth Subsalicylate
Proposed Rule Date FR Citation
Proposed Rule: Requires Reye syndrome warning [PDF] 5/5/1993 58FR26886
Proposed Rule: Adds "upset stomach" claim [PDF] 1/5/2005 70FR741

Food and Drink Overindulgence Drug Products: Stimulants
Proposed Rule Date FR Citation
Proposed Rule: Amends 21 CFR part 340 to allow stimulant and internal analgesic combinations [PDF] 12/24/1991 56FR66758
    Correction [PDF] 2/24/1992 57FR6352