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

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 Stomach Relief Liquid

ACTIVE INGREDIENT(in each 30 mL)

Bismuth subsalicylate 525 mg


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 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.

DIRECTIONS

OTHER INFORMATION

INACTIVE INGREDIENTS

benzoic acid, D&C red # 22, D&C red # 28, flavor, hydroxyethyl cellulose, potassium hydroxide, purified water, saccharin sodium, salicylic acid, simethicone, xanthan gum

PRINCIPAL DISPLAY PANEL

LEADER
NDC 70000-0439-2
Stomach Relief
Bismuth Subsalicylate, 525 mg

Upset Stomach Reliever/Anti-diarrheal

5 Symptom Digestive Relief:
Diarrhea, Heartburn, Indigestion, Nausea & Upset Stomach


COMPATE TO PEPTO-BISMOL active ingredient*

8 FL OZ (236 mL) 


53
LEADER STOMACH RELIEF 
bismuth subsalicylate liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0439
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (SALICYLIC ACID - UNII:O414PZ4LPZ) BISMUTH SUBSALICYLATE525 mg  in 30 mL
Inactive Ingredients
Ingredient NameStrength
BENZOIC ACID (UNII: 8SKN0B0MIM)  
D&C RED NO. 22 (UNII: 1678RKX8RT)  
D&C RED NO. 28 (UNII: 767IP0Y5NH)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
WATER (UNII: 059QF0KO0R)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SALICYLIC ACID (UNII: O414PZ4LPZ)  
HYDROXYETHYL CELLULOSE (1500 MPA.S AT 1%) (UNII: L605B5892V)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Product Characteristics
ColorPINKScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70000-0439-2236 mL in 1 BOTTLE; Type 0: Not a Combination Product06/07/2019
2NDC:70000-0439-1118 mL in 1 BOTTLE; Type 0: Not a Combination Product06/07/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33506/07/2019
Labeler - CARDINAL HEALTH 110, LLC. DBA LEADER (063997360)

Revised: 1/2022
Document Id: b015fc01-5c3f-4bda-9df2-442831acace9
Set id: 517ff62b-4cad-4cff-90b3-c63c1cab47b3
Version: 4
Effective Time: 20220110
 
CARDINAL HEALTH 110, LLC. DBA LEADER