Label: CVS PHARMACY EXTRA STRENGTH GAS RELIEF- simethicone antigas tablet, chewable
- NDC Code(s): 51316-011-18
- Packager: CVS
- 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 12, 2023
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient (in each tablet)
- PURPOSE
- Use
- Warnings
- Keep out of reach of children
- Directions
- Other Information
- Inactive Ingredients
- Questions or comments
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Principal Display Panel
*Compare to the active ingredient in Gas-X Extra Strength
NDC 51316-011-18
Extra strength
Gas Relief
Simethicone 125 mg/Anti-Gas
Fast Relief of Pressure, Bloating & Discomfort
Peppermint FlavorNaturally and Artificially Flavored
18 Chewable Tablets
*This product is not manufactured or distributed by GSK Consumer Healthcare, the distributor of Gas-X Extra Strength.
IMPORTANT: Keep this carton for future reference on full labeling.
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INGREDIENTS AND APPEARANCE
CVS PHARMACY EXTRA STRENGTH GAS RELIEF
simethicone antigas tablet, chewableProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51316-011 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE 125 mg Inactive Ingredients Ingredient Name Strength D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2) MAGNESIUM STEARATE (UNII: 70097M6I30) MALTODEXTRIN (UNII: 7CVR7L4A2D) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SUCRALOSE (UNII: 96K6UQ3ZD4) TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) Product Characteristics Color YELLOW Score no score Shape ROUND Size 14mm Flavor PEPPERMINT Imprint Code RP110 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51316-011-18 2 in 1 CARTON 08/05/2021 1 9 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part332 08/05/2021 Labeler - CVS (062312574)