Label: GAS RELIEF MINT FLAVOR- simethicone tablet, chewable
- NDC Code(s): 68163-111-36
- Packager: Raritan Pharmaceuticals Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated September 1, 2023
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- Active ingredient (in each tablet)
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INGREDIENTS AND APPEARANCE
GAS RELIEF MINT FLAVOR
simethicone tablet, chewableProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68163-111 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE 80 mg Inactive Ingredients Ingredient Name Strength DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2) PEPPERMINT (UNII: V95R5KMY2B) MAGNESIUM STEARATE (UNII: 70097M6I30) MALTODEXTRIN (UNII: 7CVR7L4A2D) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) TRICALCIUM PHOSPHATE (UNII: K4C08XP666) Product Characteristics Color WHITE Score no score Shape ROUND Size 13mm Flavor PEPPERMINT Imprint Code RP111 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68163-111-36 36 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 04/17/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part332 04/17/2019 Labeler - Raritan Pharmaceuticals Inc (127602287)