Label: ULTRA STRENGTH GAS RELIEF- simethicone capsule, liquid filled
- NDC Code(s): 59726-530-10
- Packager: P & L Development, LLC
- 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 April 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 the active ingredient in Phazyme® Ultra Strength†
Ultra Strength
Gas Relief
Simethicone 180 mg
Anti-gas
Fast Relief of:
• Pressure • Bloating • Discomfort
Softgels
Small, easy to swallow
†This product is not manufactured or distributed by C.B. Fleet Company Inc., distributor of Phazyme®.
TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.
Distributed by:
PL Developments
200 Hicks Street
Westbury, NY 11590
- Package Label
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INGREDIENTS AND APPEARANCE
ULTRA STRENGTH GAS RELIEF
simethicone capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59726-530 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 SILICON DIOXIDE (UNII: ETJ7Z6XBU4) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) GELATIN (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) Product Characteristics Color orange (ORANGE) Score no score Shape OVAL (OVAL) Size 11mm Flavor Imprint Code S180 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59726-530-10 1 in 1 BOX 09/01/2011 09/01/2024 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 09/01/2011 09/01/2024 Labeler - P & L Development, LLC (800014821)