Label: GAS RELIEF ULTRA STRENGTH- simethicone capsule, liquid filled
- NDC Code(s): 36800-963-50
- Packager: TOP CARE (Topco Associates LLC)
- 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 November 28, 2022
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- Active ingredient (in each softgel)
- Purpose
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- Inactive ingredients
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Principal Display Panel
COMPARE TO GAS-X® ULTRA STRENGTH ACTIVE NGREDIENT*
ULTRA STRENGTH
Gas Relief
ANTI-GAS/SIMETHICONE, 180 mg
FAST RELIEF OF
- Bloating
- Pressure
- Fullness & Gas
SOFTGELS
**This product is not manufactured or distributed by GSK Consumer Healthcare, distributor of Gas-X® Ultra Strength.
TAMPER EVIDENT: DO NOT USE IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.
DISTRIBUTED BY TOPCO ASSOCIATES LLC
ELK GROVE VILLAGE, IL 60007
- Package Label
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INGREDIENTS AND APPEARANCE
GAS RELIEF ULTRA STRENGTH
simethicone capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:36800-963 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE 180 mg Inactive Ingredients Ingredient Name Strength FD&C YELLOW NO. 6 (UNII: H77VEI93A8) GELATIN (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) FD&C RED NO. 40 (UNII: WZB9127XOA) Product Characteristics Color orange Score no score Shape OVAL Size 12mm Flavor Imprint Code 05A Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:36800-963-50 50 in 1 BOX 07/30/2020 1 1 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 07/30/2020 Labeler - TOP CARE (Topco Associates LLC) (006935977)