Label: MAXIMUM STRENGTH GAS RELIEF- simethicone capsule, liquid filled
- NDC Code(s): 63868-975-06
- Packager: Chain Drug Marketing Association, 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 July 25, 2023
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Drug Facts
- Active ingredient (in each softgel)
- Purpose
- Uses
- Warnings
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
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SPL UNCLASSIFIED SECTION
QUALITY CHOICE
*Compare to the active Ingredient in Maximum Strength Phazyme®
TAMPER EVIDENT: DO NOT USE IF PRINTED SEAL UNDER CAP IS CUT TORN OR MISSING
*This product is not manufactured or distributed by C.B. Fleet Company Inc., distributor of PHAZYME®.
Product of UAE
Packaged and Qualify Assured in the USA
REV.01-092022
QC 100% SATISFACTION GUARANTEED
Distributed by CDMA, Inc.
Novi, MI 48375
www.qualitychoice.com
Questions: 800-935-2362 - Packaging
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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:63868-975 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, UNSPECIFIED (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) PEPPERMINT OIL (UNII: AV092KU4JH) WATER (UNII: 059QF0KO0R) Product Characteristics Color purple Score no score Shape OVAL (oblong) Size 12mm Flavor Imprint Code 813 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63868-975-06 1 in 1 CARTON 03/28/2023 1 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 03/28/2023 Labeler - Chain Drug Marketing Association, Inc. (011920774)