RUGBY GAS RELIEF - simethicone tablet, chewable 
Rugby Laboratories

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.

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Rugby Gas Relief Chewable Tablets

ACTIVE INGREDIENT(in each tablet)

Simethicone 80 mg

PURPOSE

Antigas

USE(S)

relieves:


WARNINGS

Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately. 

KEEP OUT OF REACH OF CHILDREN

In case of overdose, get medical help or contact a Poison Control Center immediately. 

DIRECTIONS

OTHER INFORMATION

INACTIVE INGREDIENTS

compressible sugar, dextrose, flavor, magnesium stearate, maltodextrin, microcrystalline cellulose, sorbitol.

QUESTIONS OR COMMENTS?

1 (800) 645-2158

PRINCIPAL DISPLAY PANEL

NDC 0536-1207-04
Rugby
GAS
RELIEF
LACTOSE FREE
Simethicone 80 mg each
ANTIFLATULENT

100 CHEWABLE TABLETS



103
RUGBY GAS RELIEF 
simethicone tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-1207
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE80 mg
Inactive Ingredients
Ingredient NameStrength
SUGARCANE (UNII: 81H2R5AOH3)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
ColorWHITEScoreno score
ShapeROUNDSize13mm
FlavorPEPPERMINTImprint Code G103
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0536-1207-04100 in 1 BOTTLE; Type 0: Not a Combination Product04/25/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33204/25/2019
Labeler - Rugby Laboratories (079246066)
Establishment
NameAddressID/FEIBusiness Operations
Guardian Drug Company119210276MANUFACTURE(0536-1207)

Revised: 1/2022
Document Id: a8229dc3-975f-4b10-b713-725bf0835828
Set id: 7cc926e0-452e-4c8d-9d06-970b761066bb
Version: 3
Effective Time: 20220106
 
Rugby Laboratories