Label: MAXIMUM STRENGTH GAS RELIEF- simethicone capsule, liquid filled
- NDC Code(s): 69842-068-04, 69842-068-22
- Packager: CVS PHARMACY, 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 13, 2016
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- Official Label (Printer Friendly)
- Active ingredient (in each softgel)
- Purpose
- Use
- Warnings
- Directions
- Other information
- Inactive ingredients
- Questions or Comments?
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PRINCIPAL DISPLAY PANEL
CVS MAXIMUM STRENGTH GAS RELIEF
SIMETHICONE 250 mg
Anti-gas
NDC 69842-068-04
Compare to the active ingredient in PHAZYME® Maximum Strength
24 Liquid-Filled SoftGels
CVS MAXIMUM STRENGTH GAS RELIEF
SIMETHICONE 250 mg
Anti-gas
NDC 69842-068-22
Compare to the active ingredient in PHAZYME® Maximum Strength
60 Liquid-Filled SoftGels
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INGREDIENTS AND APPEARANCE
MAXIMUM STRENGTH GAS RELIEF
simethicone capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69842-068 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE 250 mg Inactive Ingredients Ingredient Name Strength D&C RED NO. 33 (UNII: 9DBA0SBB0L) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) GELATIN (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) Product Characteristics Color purple Score no score Shape capsule (oval) Size 13mm Flavor Imprint Code PC31 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69842-068-04 2 in 1 CARTON 12/13/2016 1 12 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:69842-068-22 1 in 1 CARTON 12/13/2016 2 60 in 1 BOTTLE, PLASTIC; 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 12/13/2016 Labeler - CVS PHARMACY, INC. (062312574) Establishment Name Address ID/FEI Business Operations Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd. 421293287 manufacture(69842-068) , analysis(69842-068)