Label: QUALITY CHOICE GAS RELIEF EXTRA STRENGTH SOFTGELS- simethicone capsule, liquid filled
- NDC Code(s): 63868-586-30
- Packager: Chain Drug Marketing Association
- 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 29, 2022
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- Official Label (Printer Friendly)
- Active ingredient (in each softgel)
- Purpose
- Use
- Warnings If pregnant or breast-feeding, ask a health professional before use.
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
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INGREDIENTS AND APPEARANCE
QUALITY CHOICE GAS RELIEF EXTRA STRENGTH SOFTGELS
simethicone capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63868-586 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 TYPE B BOVINE (230 BLOOM) (UNII: WIL1404U79) GLYCERIN (UNII: PDC6A3C0OX) PEPPERMINT OIL (UNII: AV092KU4JH) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) SORBITOL (UNII: 506T60A25R) Product Characteristics Color GREEN Score no score Shape OVAL Size 10mm Flavor Imprint Code SCU Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63868-586-30 2 in 1 CARTON 12/02/2020 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 12/02/2020 Labeler - Chain Drug Marketing Association (011920774) Registrant - Reese Pharmaceutical Co (004172052) Establishment Name Address ID/FEI Business Operations Swiss Caps Romania 565466997 manufacture(63868-586)