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 Extra Strength Gas Relief Chewable Tablets

ACTIVE INGREDIENT(in each tablet)

Simethicone 125 mg

PURPOSE

Anti-gas

USE(S)

relieves:


WARNINGS

.

KEEP OUT OF REACH OF CHILDREN

Keep out of the 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

COMPARE TO ACTIVE INGREDIENT IN GAS-X® EXTRA STRENGTH*
NDC 0536-1223-08
Rugby
EXTRA STRENGTH
GAS

RELIEF
LACTOSE FREE
Simethicone 125 mg each
Antiflatulent

60 CHEWABLE TABLETS



131
RUGBY GAS RELIEF 
simethicone tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-1223
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE125 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
ShapeROUNDSize16mm
FlavorPEPPERMINTImprint Code GDC131
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0536-1223-0860 in 1 BOTTLE; Type 0: Not a Combination Product04/29/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33204/29/2019
Labeler - Rugby Laboratories (079246066)
Establishment
NameAddressID/FEIBusiness Operations
Guardian Drug Company119210276MANUFACTURE(0536-1223)

Revised: 1/2022
Document Id: df6aa060-9f28-4d72-860c-497339bbcd19
Set id: 9b84f74f-8609-489d-b411-3103afa1b5c2
Version: 3
Effective Time: 20220105
 
Rugby Laboratories