Label: GAS RELIEF EXTRA STRENGTH- simethicone capsule, liquid filled
- NDC Code(s): 55319-487-30, 55319-487-50
- Packager: Family Dollar (FAMILY WELLNESS)
- Category: HUMAN OTC DRUG LABEL
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 25, 2023
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- Active ingredient (in each softgel)
- Purpose
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- Warnings
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- Inactive ingredients
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Principal Display Panel
COMPARE TO THE ACTIVE INGREDIENT IN GAS-X® EXTRA STRENGTH*
Gas Relief
SIMETHICONE 125 mg ANTIGAS
FAST RELIEF OF
PRESSURE - BLOATING - DISCOMFORT
EXTRA STRENGTH
SOFTGELS
†This product is not manufactured or distributed by GSK Consumer 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: MIDWOOD BRANDS, LLC
500 VOLVO PARKWAY, CHESAPEAKE, VA 23320
- 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:55319-487 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) MANNITOL (UNII: 3OWL53L36A) 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:55319-487-50 50 in 1 CARTON 02/29/2016 10/30/2025 1 1 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:55319-487-30 30 in 1 CARTON 02/29/2016 10/30/2025 2 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 02/29/2016 10/30/2025 Labeler - Family Dollar (FAMILY WELLNESS) (024472631)