GAS RELIEF - simethicone tablet, chewable 
Physicians Total Care, Inc.

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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Leader 44-137

Active ingredients

 Simethicone 80 mg

Purpose

 Antigas

Use(s)

 relieves these symptoms associated with gas

Warnings

If pregnant or breast-feeding,

 ask a health professional before use.

Keep out of reach of children.

Directions

Other information

Inactive ingredients

 dextrose, peppermint flavor, silica gel, sorbitol, stearic acid, talc, tri-calcium phosphate

Principal display panel

NDC 54868-2860-0

Product Packaging

Simethicone 80 mg

Gas Relief

•Pressure   •Bloating   •Discomfort

Fast Acting

Anti Gas

Mind Flavored

100 Tablets

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

50844  REV1104E13712

DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017



Additional barcode labeling by:
Physicians Total Care, Inc.
Tulsa, Oklahoma       74146

GAS RELIEF 
simethicone tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54868-2860(NDC:37205-112)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE80 mg
Inactive Ingredients
Ingredient NameStrength
DEXTROSE (UNII: IY9XDZ35W2)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
TALC (UNII: 7SEV7J4R1U)  
Product Characteristics
ColorWHITEScoreno score
ShapeROUNDSize13mm
FlavorPEPPERMINTImprint Code 44;137
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54868-2860-0100 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33205/17/1995
Labeler - Physicians Total Care, Inc. (194123980)
Establishment
NameAddressID/FEIBusiness Operations
Physicians Total Care, Inc.194123980relabel

Revised: 5/2012
Document Id: 27e21629-a817-4252-aa59-275b035ad251
Set id: 69840f03-0fbb-49b4-a85f-e85f3f22cf20
Version: 1
Effective Time: 20120502
 
Physicians Total Care, Inc.