Label: GAS RELIEF ULTRA STRENGTH- simethicone capsule, liquid filled
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Contains inactivated NDC Code(s)
NDC Code(s): 53187-530-60 - Packager: LIVE BETTER (The Great Atlantic & Pacific Tea Company)
- 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 April 24, 2014
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- Active ingredient (in each softgel)
- Purpose
- Uses
- Warnings
- Directions
- Other information
- Inactive ingredients
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Principal Display Panel
*Compare to the active ingredient in Phazyme® Ultra Strength
Ultra Strength
Gas Relief
Simethicone 180 mg
Antigas
- RELIEVES BLOATING AND FULLNESS
- ALSO RELIEVES PRESSURE AND GAS
Softgels
*This product is not manufactured or distributed by C.B. Fleet Company Inc., distributor of Phazyme®.
DISTRIBUTED BY ONPOINT, INC.
2 PARAGON DRIVE
MONTVALE, NJ 07645
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.
- Product 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:53187-530 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 CAPSULE Size 12mm Flavor Imprint Code S180 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53187-530-60 1 in 1 CARTON 1 60 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part332 08/17/2010 Labeler - LIVE BETTER (The Great Atlantic & Pacific Tea Company) (001367366) Registrant - P and L Development of New York Corporation (800014821)