LEADER STOMACH RELIEF ORIGINAL STRENGTH- bismuth subsalicylate 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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Cardinal Health Stomach Relief Chewables Drug Facts

Active ingredient (in each tablet)

Bismuth subsalicylate 262 mg

Purpose

Antidiarrheal/upset stomach reliever

(total salicylate 102 mg per tablet)

Uses

relieves

travelers’ diarrhea
diarrhea
upset stomach due to overindulgence in food and drink, including:
heartburn
indigestion
nausea
gas
fullness

Warnings

Reye’s syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye’s syndrome, a rare but serious illness.

Allergy alert: Contains salicylate. Do not take if you are

allergic to salicylates (including aspirin)
taking other salicylate products

Do not use if you have

bloody or black stool
an ulcer
a bleeding problem

Ask a doctor before use if you have

fever
mucus in the stool

Ask a doctor or pharmacist before use if you are

taking any drug for

anticoagulation (thinning the blood)
diabetes
gout
arthritis

When using this product

a temporary, but harmless, darkening of the stool and/or tongue may occur

Stop use and ask a doctor if

symptoms get worse
ringing in the ears or loss of hearing occurs
diarrhea lasts more than 2 days

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

chew or dissolve tablets in mouth
drink plenty of clear fluids to help prevent dehydration caused by diarrhea
adults and children 12 years and older: 2 tablets every ½ to 1 hour, or 4 tablets every hour as needed
do not exceed 16 tablets in 24 hours
use until diarrhea stops but not more than 2 days
children under 12 years: ask a doctor

Other information

each tablet contains: salicylate 102 mg
Do not use if individual blister compartments are torn or open
Store at room temperature 59°-86°F

Inactive ingredients

flavor, magnesium stearate, microcrystalline cellulose, red #27 aluminum lake, sorbitol, sucralose

Questions?

1-800-719-9260

Principal Display Panel

LEADER

NDC 37205-720-65

Compare to Pepto-Bismol® active ingredient*

Pink Bismuth

Chewable Tablets

Bismuth Subsalicylate 262 mg

Original Flavor

Provides Soothing Relief for:

Indigestion
Upset Stomach
Nausea
Diarrhea
Heartburn

SATISFACTION GUARANTEED

30 CHEWABLE TABLETS

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

Distributed By: Cardinal Health

Dublin, Ohio 43017

www.myleader.com

CIN 2572691

*This product is not manufactured or distributed by Procter & Gamble Inc., the distributor of PEPTO-BISMOL®.

Pink Bismuth Chewable Tablets

Stomach Relief Chewables Carton

LEADER STOMACH RELIEF  ORIGINAL STRENGTH
bismuth subsalicylate tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37205-720
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (SALICYLIC ACID - UNII:O414PZ4LPZ) BISMUTH SUBSALICYLATE262 mg
Inactive Ingredients
Ingredient NameStrength
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
SORBITOL (UNII: 506T60A25R)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
Product Characteristics
ColorPINKScoreno score
ShapeROUNDSize17mm
FlavorImprint Code L469
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:37205-720-655 in 1 CARTON08/20/2019
16 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33508/20/2019
Labeler - Cardinal Health (097537435)

Revised: 1/2021
Document Id: 00f50371-76c2-4b48-b082-6cb7de82e5cb
Set id: f142cf23-58fb-4078-9ab7-dca60934f8fc
Version: 5
Effective Time: 20210122
 
Cardinal Health