Label: GAS RELIEF ULTRA STRENGTH- simethicone capsule, liquid filled
- NDC Code(s): 21130-530-60
- Packager: Safeway, 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 November 5, 2021
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- Active ingredient (in each softgel)
- Purpose
- Uses
- Warnings
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- Other information
- Inactive ingredients
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Principal Display Panel
COMPARE TO Phazyme® Ultra Strength active ingredient**
Ultra Strength
Gas Relief
SIMETHICONE 180 mg
Antigas
Fast relief of:
- Pressure
- Bloating
- Discomfort
Small, Easy to Swallow
SOFTGEL
*This product is not manufactured or distributed by C.B. Fleet Company Inc., distributor of Phazyme®.
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.
KEEP OUTER CARTON FOR COMPLETS WARNINGS AND PRODUCT INFORMATION
DISTRIBUTED BY
BETTER LIVING BRANDS LLC
P.O. BOX 99, PLEASANTON, CA 94566-0009
- 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:21130-530 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) WATER (UNII: 059QF0KO0R) Product Characteristics Color orange Score no score Shape OVAL Size 12mm Flavor Imprint Code S180 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:21130-530-60 1 in 1 BOX 12/31/2015 05/31/2024 1 60 in 1 BOTTLE, PLASTIC; 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 12/31/2015 05/31/2024 Labeler - Safeway, Inc. (009137209)