GAS RELIEF- dimethicone tablet, chewable 
CARDINAL HEALTH

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

  • bloating
  • pressure
  • stuffed feeling
  • fullness

Warnings

If pregnant or breast-feeding,

 ask a health professional before use.

Keep out of reach of children.

Directions

  •  do not exceed 6 tablets per day unless directed by a doctor
  • chew 1 to 2 tablets thoroughly as needed after meals and at bedtime

Other information

  • store at room temperature
  • avoid high humidity and excessive heat, above 40ºC (104ºF) 

Inactive ingredients

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

Principal display panel

 LEADER®

NDC 37205-112-78

Compare to Mylanta® Gas active ingredient*

Simethicone 80 mg

Gas Relief

•Pressure   •Bloating   •Discomfort

Fast Acting

Anti Gas

Mind Flavored

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

50844  REV1104E13712

DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017

Product Packaging

GAS RELIEF 
simethicone tablet, chewable
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:37205-112
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (DIMETHICONE) DIMETHICONE80 mg
Inactive Ingredients
Ingredient NameStrength
DEXTROSE 
SILICON DIOXIDE 
TALC 
Product Characteristics
ColorWHITEScoreno score
ShapeROUNDSize13mm
FlavorPEPPERMINTImprint Code 44;137
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:37205-112-78100 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33207/28/1994
Labeler - CARDINAL HEALTH (097537435)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.038154464PACK(37205-112, 37205-112)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867837MANUFACTURE(37205-112, 37205-112)

Revised: 2/2012
Document Id: 984f693e-12bc-4c76-9c7a-8c393f1ea01d
Set id: 359bf5e1-1c08-4c52-bfee-e490857e56da
Version: 7
Effective Time: 20120201
 
CARDINAL HEALTH