Label: GAS RELIEF ULTRA STRENGTH- simethicone capsule, liquid filled
- NDC Code(s): 68788-7890-3, 68788-7890-6
- Packager: Preferred Pharmaceuticals Inc.
- This is a repackaged label.
- Source NDC Code(s): 0536-1306
- 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 September 22, 2023
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Active ingredient (in each softgel)
- Purpose
- Uses
- Warnings
- Directions
- Other information
- Inactive ingredients
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Principal Display Panel
Compare to the active ingredient in Phazyme® Ultra Strength†
Ultra Strength
Simethicone 180 mg
Antigas
Fast relief of
- •
- Gas
- •
- Pressure
- •
- Bloating
- •
- Discomfort
†This product is not manufactured or distributed by C.B. Fleet Company Inc., distributor of Phazyme® Ultra Strength
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
Distributed by:
RUGBY® LABORATORIES
17177 N Laurel Park Drive,
Suite 233
Livonia, MI 48152
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- Product Label
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INGREDIENTS AND APPEARANCE
GAS RELIEF ULTRA STRENGTH
simethicone capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68788-7890(NDC:0536-1306) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE 180 mg Inactive Ingredients Ingredient Name Strength FD&C YELLOW NO. 6 (UNII: H77VEI93A8) GELATIN, UNSPECIFIED (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) FD&C RED NO. 40 (UNII: WZB9127XOA) Product Characteristics Color ORANGE Score no score Shape CAPSULE Size 12mm Flavor Imprint Code 05A Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68788-7890-3 30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 04/23/2021 2 NDC:68788-7890-6 36 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 04/23/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part332 04/23/2021 Labeler - Preferred Pharmaceuticals Inc. (791119022) Registrant - Preferred Pharmaceuticals Inc. (791119022) Establishment Name Address ID/FEI Business Operations Preferred Pharmaceuticals Inc. 791119022 REPACK(68788-7890)
