Label: GAS RELIEF ULTRA STRENGTH- simethicone capsule, liquid filled
- NDC Code(s): 0363-8730-20
- Packager: Walgreens
- 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 29, 2022
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- Active ingredient (in each softgel)
- Purpose
- Uses
- Warnings
- Directions
- Other information
- Inactive ingredients
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Principal Display Panel
Compare to the active ingredient in Phazyme® Ultra Strength††
Gas Relief
SIMETHICONE 180 mg / ANTI-GAS
ULTRA STRENGTH
SOFTGELS
- For fast relief of pressure, bloating & fullness
SOFTGELS
††This product is not manufactured or distributed by C.B. Fleet Company Inc., distributor of Phazyme® 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: WALGREEN CO
200 WILMOT RD., DEERFIELD, IL 60015
- Product 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:0363-8730 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 CAPSULE Size 12mm Flavor Imprint Code 05A Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0363-8730-20 20 in 1 CARTON 04/30/2020 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 04/30/2020 Labeler - Walgreens (008965063)