STOMACH RELIEF - bismuth subsalicylate tablet, chewable 
CARDINAL HEALTH 110, LLC. DBA LEADER

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Leader Stomach Relief

ACTIVE INGREDIENT(in each tablet)

Bismuth subsalicylate 262 mg

(total salicylate 102 mg per tablet)


PURPOSE

Upset stomach reliever and anti-diarrheal

USE(S)

relieves:


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


DO NOT USE IF YOU HAVE

ASK A DOCTOR BEFORE USE IF YOU HAVE

ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE

taking any drug for 


WHEN USING THIS PRODUCT

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

STOP USE AND ASK A DOCTOR IF

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 immediately (1-800-222-1222).

DIRECTIONS

OTHER INFORMATION

INACTIVE INGREDIENTS

calcium carbonate, D&C red 27 aluminum lake, flavor, magnesium stearate, mannitol, pregelatinized starch, saccharin sodium

PRINCIPAL DISPLAY PANEL

LEADER

NDC 70000-0591-1
Stomach Relief

Bismuth Subsalicylate, 262 mg
Upset Stomach Reliever / Anti-Diarrheal

COMPARE TO PEPTO-BISMOL® active ingredient*

5 Symptom Digestive Relief: 

Diarrhea

Heartburn

Indigestion

Nausea

Upset stomach



30 CHEWABLE TABLETS



122-30-ldr.jpg



LEADER

NDC 70000-0591-2
Stomach Relief

Bismuth Subsalicylate, 262 mg
Upset Stomach Reliever / Anti-Diarrheal

COMPARE TO PEPTO-BISMOL® active ingredient*

5 Symptom Digestive Relief: 

Diarrhea

Heartburn

Indigestion

Nausea

Upset stomach



48 CHEWABLE TABLETS


122-48-ldr.jpg

STOMACH RELIEF 
bismuth subsalicylate tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0591
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
CALCIUM CARBONATE (UNII: H0G9379FGK)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MANNITOL (UNII: 3OWL53L36A)  
STARCH, CORN (UNII: O8232NY3SJ)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
Product Characteristics
ColorPINKScoreno score
ShapeROUNDSize16mm
FlavorImprint Code G122
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70000-0591-15 in 1 BOX10/05/2021
16 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:70000-0591-28 in 1 BOX10/05/2021
26 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00810/05/2021
Labeler - CARDINAL HEALTH 110, LLC. DBA LEADER (063997360)
Establishment
NameAddressID/FEIBusiness Operations
Guardian Drug Company119210276MANUFACTURE(70000-0591)

Revised: 1/2025
Document Id: 227d63ba-9ab8-4895-9ba1-7b3c9e2100d3
Set id: b38d815b-a249-46d1-a9d0-4e8efab3e56b
Version: 5
Effective Time: 20250106
 
CARDINAL HEALTH 110, LLC. DBA LEADER