Label: RUGBY GAS RELIEF- simethicone tablet, chewable
- NDC Code(s): 0536-1223-08
- Packager: Rugby Laboratories
- 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 January 5, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT(in each tablet)
- PURPOSE
- USE(S)
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
RUGBY GAS RELIEF
simethicone tablet, chewableProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0536-1223 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 SUGARCANE (UNII: 81H2R5AOH3) MALTODEXTRIN (UNII: 7CVR7L4A2D) DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) SORBITOL (UNII: 506T60A25R) Product Characteristics Color WHITE Score no score Shape ROUND Size 16mm Flavor PEPPERMINT Imprint Code GDC131 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0536-1223-08 60 in 1 BOTTLE; Type 0: Not a Combination Product 04/29/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part332 04/29/2019 Labeler - Rugby Laboratories (079246066) Establishment Name Address ID/FEI Business Operations Guardian Drug Company 119210276 MANUFACTURE(0536-1223)