NDC | 41520-487-30 |
Set ID | ef1c668c-4af3-40b1-ba38-2f37becdfe07 |
Category | HUMAN OTC DRUG LABEL |
Packager | Care One (American Sales Company) |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART347 |
- 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 the active ingredient in Gas-X® Extra Strength†
EXTRA STRENGTH
GAS RELIEF
Simethicone 125 mg Antigas
RELIEVES:
PRESSURE, BLOATING, FULLNESS, GAS
SOFTGELS
**This product is not manufactured or distributed GSK Comsumer Healthcare, distributor of Gas-X® Extra 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 FOODHOLD U.S.A., LLC
LANDOVER, MD 20785 • 1-877-846-9949
- 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:41520-487 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:41520-487-30 30 in 1 CARTON 11/30/2016 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 part347 11/30/2016 Labeler - Care One (American Sales Company) (809183973)