Label: GAS RELIEF EXTRA STRENGTH- simethicone capsule, liquid filled
- NDC Code(s): 49035-487-02, 49035-487-15, 49035-487-72
- Packager: EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART 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 January 20, 2023
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- Active ingredient (in each softgel)
- Purpose
- Uses
- Warnings
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
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Principal Display Panel
Compare to Gas-X® Extra Strength Active Ingredient**
Extra Strength
Gas Relief
Simethicone 125 mg Antigas
Fast Relief of:
- Pressure
- Bloating
- Discomfort
Small, easy to swallow
SOFTGELS
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER CAP IS BROKEN OR MISSING.
**This product is not manufactured or distributed by GSK Consumer Healthcare, distributor of Gas-X® Extra Strength.
DISTRIBUTED BY:
Walmart Inc.,
Bentonville, AR 72716
- Product Label
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INGREDIENTS AND APPEARANCE
GAS RELIEF EXTRA STRENGTH
simethicone capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49035-487 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) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 40 (UNII: WZB9127XOA) GELATIN (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) PEPPERMINT OIL (UNII: AV092KU4JH) WATER (UNII: 059QF0KO0R) SORBITAN (UNII: 6O92ICV9RU) SORBITOL (UNII: 506T60A25R) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color green Score no score Shape OVAL Size 9mm Flavor Imprint Code PO;SCU;L125 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49035-487-02 20 in 1 CARTON 03/31/2016 03/31/2025 1 1 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:49035-487-15 150 in 1 CARTON 03/31/2016 03/31/2025 2 1 in 1 BLISTER PACK; Type 0: Not a Combination Product 3 NDC:49035-487-72 72 in 1 CARTON 03/31/2016 03/31/2025 3 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 part347 03/31/2016 03/31/2025 Labeler - EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC) (051957769)