Label: GAS RELIEF ULTRA STRENGTH- simethicone capsule, liquid filled
- NDC Code(s): 49035-530-20
- Packager: EQUATE (Walmart Stores, Inc.)
- 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.
Updated December 31, 2012
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- Active ingredient (in each softgel)
Simethicone 180 mgClose
- relieves bloating, pressure, or fullness commonly referred to as gas
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away.
- swallow one or two softgels as needed after a meal
- do not exceed two softgels per day except under the advice and supervision of a physician
- Other information
- store at controlled room temperature 15º-30ºC (59º-86ºF)
- Inactive ingredients
edibile ink, FD&C yellow # 6, gelatin, glycerin and purified waterClose
- Questions or comments?
- Principal Display Panel
Compare to Ultra Strength Phazyme® Active Ingredient*
- Gas discomfort
180 mg LIQUID-FILLED SOFTGELS
Distributed by: Wal-Mart Stores, Inc., Bentonville, AR 72716 ©Wal-Mart Stores, Inc. Product of USA
*This product is not manufactured or distributed by GlaxoSmithKline, owner of the registered trademark Ultra Strength Phazyme®.
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.
EACH DOSE IS INDIVIDUALLY SEALED IN A BLISTER PACK. DO NOT USE IF BLISTER UNIT IS TORN OR BROKEN.Close
- Package Label
Equate Simethicone 180 mg Ultra Strength Gas Relief SoftgelsClose
- INGREDIENTS AND APPEARANCE
GAS RELIEF ULTRA STRENGTH
simethicone capsule, liquid filled
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49035-530 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 OVAL Size 12mm Flavor Imprint Code S180 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49035-530-20 2 in 1 CARTON 1 10 in 1 BLISTER PACK Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part332 01/15/2013 Labeler - EQUATE (Walmart Stores, Inc.) (051957769) Registrant - P and L Development of New York Corporation (800014821)