Rulemaking History for OTC Food and Drink Overindulgence Drug Products

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Rulemaking History for OTC Food and Drink Overindulgence Drug Products
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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:

Original Active Ingredients and Labeling
Internal Analgesics
Antacids
Bismuth Subsalicylate
Stimulants

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**Food and Drink Overindulgence Drug Products: Original Active Ingredients and Labeling**
Advance Notice Of Proposed Rulemaking	Date	FR Citation
Advance Notice of Proposed Rulemaking	10/1/1982	47FR43540
Correction	12/10/1982	47FR55497
Correction	12/21/1982	47FR56871
Extension of Comment Period	1/4/1983	48FR270
Notice: Classifies "prevention of inebriation" claim as nonmonograph	7/19/1983	48FR32872
Proposed Rule	Date	FR Citation
Tentative Final Monograph	12/24/1991	56FR66742
Correction	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	12/24/1991	55FR66762

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

**Food and Drink Overindulgence Drug Products: Bismuth Subsalicylate**
Proposed Rule	Date	FR Citation
Proposed Rule: Requires Reye syndrome warning	5/5/1993	58FR26886
Proposed Rule: Adds "upset stomach" claim	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	12/24/1991	56FR66758
Correction	2/24/1992	57FR6352

Date created: December 28, 2006