Label: EXTRA STRENGTH GAS RELIEF- simethicone capsule, liquid filled
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Contains inactivated NDC Code(s)
NDC Code(s): 33992-3113-5 - Packager: Greenbrier International, 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.
Drug Label Information
Updated December 21, 2017
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (per each softgel)
- Purpose
- Use
- Warnings
- Directions
- Other information
- Inactive ingredients
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Principal Display Panel
*Compare to the active ingredient in Extra Strength Gas-X®
Assured
Extra Strength
Gas Relief
SIMETHICONE, 125mg
ANTI-GAS
Relieves:
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- Bloating
- •
- Pressure
- •
- Fullness
- •
- Gas
15 SOFTGELS
*This product is not manufactured or distributed by GSK Consumer Healthcare, Inc., the distributor of Gas-X® Extra strength.
Distributed by:Greenbrier International, Inc.
Chesapeake, VA 23320
IMPORTANT: Keep this carton for future reference on full labeling.
DO NOT USE IF ANY INDIVIDUAL BLISTER IS BROKEN OR OPEN
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INGREDIENTS AND APPEARANCE
EXTRA STRENGTH GAS RELIEF
simethicone capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:33992-3113 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) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color GREEN (Opaque) Score no score Shape OVAL Size 10mm Flavor Imprint Code PC2 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:33992-3113-5 1 in 1 CARTON 01/19/2018 1 15 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part332 01/19/2018 Labeler - Greenbrier International, Inc. (610322518)