GAS RELIEF- simethicone 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-Delisted

Active ingredient (in each tablet)

Simethicone 80 mg

Purpose

Antigas

Uses

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 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

Leader 44-137

GAS RELIEF 
simethicone tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)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
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
TALC (UNII: 7SEV7J4R1U)  
PEPPERMINT (UNII: V95R5KMY2B)  
TRICALCIUM PHOSPHATE (UNII: K4C08XP666)  
SORBITOL (UNII: 506T60A25R)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
DEXTROSE (UNII: IY9XDZ35W2)  
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; Type 0: Not a Combination Product07/28/199402/04/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33207/28/199402/04/2023
Labeler - CARDINAL HEALTH (097537435)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.038154464PACK(37205-112)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867894MANUFACTURE(37205-112)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.967626305PACK(37205-112)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.868734088PACK(37205-112)

Revised: 3/2020
Document Id: e7b24b8f-f381-427d-8fe3-701407cf9744
Set id: 359bf5e1-1c08-4c52-bfee-e490857e56da
Version: 15
Effective Time: 20200325
 
CARDINAL HEALTH