Label: GAS RELIEF EXTRA STRENGTH- simethicone capsule, liquid filled
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Contains inactivated NDC Code(s)
NDC Code(s): 68391-550-12 - Packager: BJWC (Berkley & Jensen / BJ's)
- 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.
Drug Label Information
Updated January 21, 2013
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient (in each softgel)
- Purpose
- Use
- Warnings
- Stop use and ask a doctor if
- If pregnant or breast-feeding,
- Keep out of reach of children.
- Directions
- Inactive Ingredients
- Questions or comments?
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Principal Display Panel
Compare to the active ingredient in Extra Strength Gas-X®*
Extra Strength
Gas Relief
Simethicone, 125 mg
Relieves:
- bloating
- fullness
- pressure
- gas
*This product is not manufactured or distributed by Novartis Consumer Health Inc., owner of the registered trademark Extra Strength Gas-X®
DO NOT USE IF BLISTER UNIT IS TORN OR BROKEN.
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION
- Product Label
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INGREDIENTS AND APPEARANCE
GAS RELIEF EXTRA STRENGTH
simethicone capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68391-550 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:68391-550-12 8 in 1 CARTON 1 15 in 1 BLISTER PACK Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part332 07/15/2013 Labeler - BJWC (Berkley & Jensen / BJ's) (159082692) Registrant - P and L Development of New York Corporation (800014821)