GAS RELIEF- simethicone tablet, chewable 
Safeway

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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Extra strength Gas Relief Peppermint Tablets

Active ingredient (in each tablet)

Simethicone 125 mg

Purpose

Anti-gas

Uses

relieves:

Warnings

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

D&C red 30 aluminum lake, D&C yellow 10 aluminum lake, dextrose, flavor, magnesium stearate, maltodextrin, microcrystalline cellulose, sorbitol, sucrose

PDP

*Compare to GAS-X®E-X Chewable active ingredient

Signature Care

Extra strength Gas Relief

Simethicone 125 mg

Anti-Gas

Peppermint Flavor

Relieves symptoms of gas discomfort, pressure and bloating

18 chewable tablets

Box

GAS RELIEF 
simethicone tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21130-135
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE125 mg
Inactive Ingredients
Ingredient NameStrength
D&C RED NO. 30 (UNII: 2S42T2808B)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
DEXTROSE (UNII: IY9XDZ35W2)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
ColoryellowScoreno score
ShapeROUNDSize16mm
FlavorPEPPERMINTImprint Code G134
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:21130-135-732 in 1 CARTON11/11/2015
19 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33211/11/2015
Labeler - Safeway (009137209)
Registrant - Guardian Drug Company (119210276)
Establishment
NameAddressID/FEIBusiness Operations
Guardian Drug Company119210276manufacture(21130-135)

Revised: 1/2016
Document Id: f3c5efc4-6e17-44e8-9bbc-2e2f46a4177a
Set id: 14a9fb00-707a-4b55-a060-82ad53a806e3
Version: 1
Effective Time: 20160108
 
Safeway