Label: GAS RELIEF EXTRA STRENGTH- simethicone capsule, liquid filled
- NDC Code(s): 67510-0172-1
- Packager: Kareway Product, 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.
Updated October 5, 2012
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- Active Ingredients (in each softgel)
For Relief of:
- stuffed feeling commonly referred to as gas
Keep out of reach of children
In case of overdose, get medical help or contact a Poison Control Center right away.
- adults: swallow with water 1 or 2 softgels as needed after meals or at bedtime. Do not exceed 4 softgels per day, unless directed by doctor.
- Other information
- store at a controlled room temperature 15-30°C (59-86°F)
- protect from heat and moisture
- Inactive ingreients
FD&C blue 1, FD&C yellow 5, gelatin, glycerin, purified water, titanium dioxideClose
- Package/Label Principal Display Panel
- INGREDIENTS AND APPEARANCE
GAS RELIEF EXTRA STRENGTH
simethicone capsule, liquid filled
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67510-0172 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 FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) GELATIN (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color green Score no score Shape OVAL Size 9mm Flavor Imprint Code GR Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:67510-0172-1 10 in 1 BLISTER PACK Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part332 09/01/2012 Labeler - Kareway Product, Inc. (121840057)