Label: GAS RELIEF EXTRA STRENGTH- dimethicone capsule, liquid filled
- NDC Code(s): 41520-242-30, 41520-242-36
- Packager: Care One (American Sales Company)
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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- Active ingredient (in each softgel)
Simethicone 125 mgClose
- for the relief of pressure, bloating, and fullness commonly referred to as gas
- adults: swallow with water 1 or 2 softgels as needed after meals and at bedtime
- do not exceed 4 softgels in 24 hours unless directed by a doctor
- Other information
- store at controlled room temperature 20-25°C (68-77°F)
- protect from light, heat, and moisture
- Inactive ingredients
D&C yellow #10, edible ink, FD&C blue #1, FD&C red #40, gelatin, glycerin, medium-chain triglycerides*, peppermint oil, purified water, sorbitan, sorbitol, titanium dioxide
*may contain this ingredientClose
- Questions or comments?
Call 1-877-753-3935 Monday-Friday 9AM-5PM ESTClose
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Compare to the active ingredient in Gas-X®†
SIMETHICONE 125 mg
†This product is not manufactured or distributed by Novartis, owner of the registered trademark Gas-X®.
Foodhold U.S.A., LLC
Landover, MD 20785
© 2013 Ahold Licensing, Sarl
Quality guaranteed or your money back
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.Close
- Product Label
Simethicone 125 mg softgels
- INGREDIENTS AND APPEARANCE
GAS RELIEF EXTRA STRENGTH
simethicone capsule, liquid filled
Product Information Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:41520-242 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIMETHICONE (DIMETHICONE) DIMETHICONE 125 mg Inactive Ingredients Ingredient Name Strength D&C YELLOW NO. 10 FD&C BLUE NO. 1 FD&C RED NO. 40 GELATIN GLYCERIN MEDIUM-CHAIN TRIGLYCERIDES PEPPERMINT OIL WATER SORBITAN SORBITOL TITANIUM DIOXIDE Product Characteristics Color GREEN Score no score Shape OVAL Size 9mm Flavor Imprint Code PO;S1;SCU Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:41520-242-36 2 in 1 CARTON 1 18 in 1 BLISTER PACK 2 NDC:41520-242-30 2 in 1 CARTON 2 15 in 1 BLISTER PACK Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part347 11/15/2013 Labeler - Care One (American Sales Company) (809183973)