Label: GAS RELIEF EXTRA STRENGTH- simethicone capsule, liquid filled
- NDC Code(s): 41520-550-30, 41520-550-36
- Packager: Care One (American Sales 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.
Updated December 27, 2012
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- Drug Facts
- Active Ingredient (in each softgel)
Simethicone 125 mgClose
relieves bloating, pressure, or fullness commonly referred to as gas.Close
- Stop use and ask a doctor if
- If pregnant or breast- feeding,
ask a health care professional before useClose
- Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away.Close
- adults: swallow with water 1 or 2 softgels as needed after meals and at bedtime.
- do not exceed 4 softgels in 24 hours except under the advice and supervision of a physician
- store at controlled room temperature 15°-30°C (59°-86°F)
- protect from heat and moisture
- *This product is not manufactured or distributed by Novartis Consumer Health Inc., owner of the registered trademark Extra Strength Gas- X®
- Inactive Ingredients
D&C Yellow #10, edible ink, FD&C Blue #1, FD&C Red #40, gelatin, glycerin, peppermint oil, purified water, sorbitol special, and titanium dioxideClose
- Questions or comments?
call toll free 1-877-753-3935 Monday-Friday 9AM-5PM ESTClose
- Principal Display Panel
Compare to the active ingredient in Extra Strength Gas-X®*
Simethicone 125 mg
EACH DOSE IS INDIVIDUALLY SEALED IN A BLISTER PACK.
DO NOT USE IF BLISTER UNIT IS TORN OR BROKEN.
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION
Distributed by: American Sales Company
4201 walden ave, Lancaster, NY 14086Close
- Product Label
Simethicone 125 mg
- INGREDIENTS AND APPEARANCE
GAS RELIEF EXTRA STRENGTH
simethicone capsule, liquid filled
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:41520-550 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 (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) PEPPERMINT OIL (UNII: AV092KU4JH) WATER (UNII: 059QF0KO0R) SORBITOL (UNII: 506T60A25R) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color GREEN Score no score Shape OVAL Size 9mm Flavor Imprint Code PO Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:41520-550-30 2 in 1 CARTON 1 15 in 1 BLISTER PACK 2 NDC:41520-550-36 2 in 1 CARTON 2 18 in 1 BLISTER PACK Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part332 10/27/2010 Labeler - Care One (American Sales Company) (809183973) Registrant - P and L Development of New York Corporation (800014821)