Label: LEADER GAS RELIEF EXTRA STRENGTH- simethicone capsule, liquid filled
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Contains inactivated NDC Code(s)
NDC Code(s): 37205-295-65 - Packager: Cardinal Health
- 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 22, 2021
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- Active ingredient (in each softgel)
- Purpose
- Uses
- Warnings
- Directions
- Other information
- Inactive ingredients
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Principal Display Panel
NDC 37205-295-65
Compare to Gas-X® Extra Strength active ingredient*
EXTRA STRENGTH
Gas Relief
Simethicone 125 mg
Anti-Gas
For Fast Relief of Pressure, Bloating & Discomfort
SATISFACTION GUARANTEED
30 SOFTGEL
IMPORTANT: Keep this carton for future reference on full labeling.
Distributed By: Cardinal Health
Dublin Ohio 43017
CIN 2788362
All Leader® Brand products are 100% satisfaction guaranteed or return to place of purchase for a full refund.
*This product is not manufactured or distributed by GSK Consumer Healthcare, Inc. the distributor of Gas-X® Extra Strength.
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INGREDIENTS AND APPEARANCE
LEADER GAS RELIEF EXTRA STRENGTH
simethicone capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:37205-295 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, UNSPECIFIED (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) PEPPERMINT OIL (UNII: AV092KU4JH) WATER (UNII: 059QF0KO0R) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color GREEN Score no score Shape OVAL Size 10mm Flavor Imprint Code L428 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:37205-295-65 3 in 1 CARTON 07/18/2019 1 10 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 07/18/2019 Labeler - Cardinal Health (097537435)