Label: SIMETHICONE- dimethicone capsule, liquid filled
- NDC Code(s): 0536-3604-08
- Packager: Rugby Laboratories, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Updated March 27, 2014
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- Active ingredient (in each softgel)
Simethicone 180 mgClose
- relieves bloating, pressure or fullness commonly referred to as gas
- swallow one or two softgels as needed after a meal
- do not exceed two softgels per day except under the advice and supervision of a physician
- Other information
- store at 15°-30°C (59°-86°F)
- Inactive ingredients
edible ink, FD&C yellow #6, gelatin, glycerin, purified waterClose
- Questions or comments?
- Principal Display Panel
COMPARE TO ACTIVE INGREDIENT IN ULTRA STRENGTH PHAZYME®*
Simethicone 180 mg
Relieves Symptoms of Gas
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.
*Rugby Laboratories is not affiliated with the owner of the trademark Ultra Strength Phazyme®.
Distributed by: Rugby Laboratories
31778 Enterprise Drive
Livonia, MI 48150
- PRODUCT LABEL
Rugby Simethicone 180 mg Softgel
- INGREDIENTS AND APPEARANCE
simethicone capsule, liquid filled
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0536-3604 Route of Administration ORAL DEA Schedule 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 (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) Product Characteristics Color ORANGE Score no score Shape OVAL Size 12mm Flavor Imprint Code S180 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0536-3604-08 60 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part332 05/09/2012 Labeler - Rugby Laboratories, Inc. (191427277)