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Gas Relief by CARDINAL HEALTH

Dosage form: tablet, chewable
Ingredients: SIMETHICONE 80mg
Labeler: CARDINAL HEALTH
NDC Code: 37205-112

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.

Leader 44-137

Active ingredient (in each tablet)

Simethicone 80 mg

Purpose

Antigas

Uses
  • relieves these symptoms associated with gas:
    • bloating
    • pressure
    • fullness
    • stuffed feeling 

Warnings

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

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

Other information
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • avoid high humidity and excessive heat above 40ºC (104ºF) 
  • use by expiration date on package

Inactive ingredients

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

Principal Display Panel

NDC 37205-112-78

LEADER®

Gas Relief
Simethicone 80 mg

Anti Gas
• Pressure   • Bloating   • Discomfort

Fast Acting

SATISFACTION GUARANTEED

Mint Flavored

100 CHEWABLE TABLETS

50844  REV0712G13712

Questions or comments? 1-800-426-9391

DISTRIBUTED BY CARDINAL HEALTH
DUBLIN, OHIO 43017
www.myleader.com    1-800-200-6313

CIN 2804144

All Leader® Brand products are 100% satisfaction guaranteed or return to place of purchase for a full refund.

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

Leader 44-137

GAS RELIEF 
simethicone tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37205-112
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SIMETHICONE (SIMETHICONE) SIMETHICONE80 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE 
TALC 
PEPPERMINT 
TRICALCIUM PHOSPHATE 
SORBITOL 
STEARIC ACID 
Product Characteristics
ColorWHITEScoreno score
ShapeROUNDSize13mm
FlavorPEPPERMINTImprint Code44;137
Contains    
Packaging
#Item CodePackage Description
1NDC:37205-112-78100 TABLET, CHEWABLE 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/FEIOperations
LNK International, Inc.038154464PACK(37205-112)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867894MANUFACTURE(37205-112)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.967626305PACK(37205-112)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.868734088PACK(37205-112)

 
CARDINAL HEALTH

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Medically reviewed on Mar 14, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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