Label: GAS RELIEF ULTRA STRENGTH- simethicone capsule
- NDC Code(s): 49348-489-12
- Packager: McKesson (Sunmark)
- 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 May 29, 2014
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- Active ingredient (in each softgel)
Simethicone 180 mgClose
- relieves bloating, pressure, or fullness commonly referred to as gas
- 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 15º-30ºC (59º-86ºF)
- Inactive ingredients
edible ink, FD&C yellow #6, gelatin, glycerin, purified waterClose
- Questions or comments?
Call 1-877-753-3935 Monday-Friday 9AM-5PM ESTClose
- Principal Display Panel
COMPARE TO PHAZYME® ULTRA STRENGTH ACTIVE INGREDIENT*
Ultra Strength Antigas
Relieves bloating, pressure, fullness & gas
Simethicone 180 mg
RELIEVES GAS SYMPTOMS
SOFTGELS 180 mg EACH
*This product is not manufactured or distributed by C.B. Fleet Company, Inc., distributor of Phazyme®.
Another Quality Product Distributed by McKesson
One Post Street, San Francisco, CA 94104
Please visit us at www.sunmarkbrand.com
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.Close
- Product Label
Sunmark Gas Relief Softgel
- INGREDIENTS AND APPEARANCE
GAS RELIEF ULTRA STRENGTH
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49348-489 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:49348-489-12 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 07/09/2010 Labeler - McKesson (Sunmark) (177667227)