Cardinal Health Stomach Relief Drug Facts

Leader Stomach Relief by

Drug Labeling and Warnings

Leader Stomach Relief by is a Otc medication manufactured, distributed, or labeled by Cardinal Health. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

LEADER STOMACH RELIEF- bismuth subsalicylate suspension 
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 Drug Facts

Active ingredient (in each 30 mL)

Bismuth subsalicylate 525 mg

Purposes

Upset stomach reliever and antidiarrheal

Uses

relieves

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

  • an ulcer
  • a bleeding problem
  • bloody or black stool

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
  • diarrhea lasts more than 2 days
  • ringing in the ears or loss of hearing occurs

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 (1-800-222-1222).

Directions

  • shake well before use
  • only use the dose cup provided
  • adults and children 12 years and over: 1 dose (30 mL) every 1/2 to 1 hour as needed
  • do not exceed 8 doses (240 mL) in 24 hours
  • use until diarrhea stops but not more than 2 days
  • children under 12 years: ask a doctor
  • drink plenty of clear fluids to help prevent dehydration caused by diarrhea

Other information

  • each 30 mL contains: magnesium 15 mg, potassium 5 mg and sodium 12 mg
  • salicylate 254 mg
  • low sodium
  • store at 20-25°C (68-77°F). Avoid excessive heat over 104°F (40°C).
  • protect from freezing
  • does not meet USP requirements for pH
  • for health information visit www.more-info.info

Inactive ingredients

D&C red #22, D&C red #28, magnesium aluminum silicate, methyl salicylate, methylcellulose, purified water, saccharin sodium, salicylic acid, sodium salicylate, sorbic acid, xanthan gum

Questions or comments?

1-800-719-9260

Principal Display Panel

Compare to Pepto-Bismol® active ingredient

ORIGINAL STRENGTH

Stomach Relief

Bismuth Subsalicylate 525 mg per 30 mL

Upset Stomach Reliever

Anti-diarrheal

5 Symptom Digestive Relief

Heartburn - Indigestion

Upset Stomach

Nausea – Diarrhea

SATISFACTION GUARANTEED

8 FL OZ (237 mL)

Stomach Relief image
LEADER STOMACH RELIEF 
bismuth subsalicylate suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 49781-025
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (BISMUTH CATION - UNII:ZS9CD1I8YE, SALICYLIC ACID - UNII:O414PZ4LPZ) BISMUTH SUBSALICYLATE525 mg  in 30 mL
Inactive Ingredients
Ingredient NameStrength
D&C RED NO. 22 (UNII: 1678RKX8RT)  
D&C RED NO. 28 (UNII: 767IP0Y5NH)  
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
WATER (UNII: 059QF0KO0R)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SALICYLIC ACID (UNII: O414PZ4LPZ)  
SODIUM SALICYLATE (UNII: WIQ1H85SYP)  
SORBIC ACID (UNII: X045WJ989B)  
XANTHAN GUM (UNII: TTV12P4NEE)  
METHYL SALICYLATE (UNII: LAV5U5022Y)  
Product Characteristics
ColorPINK (viscous) Score    
ShapeSize
FlavorWINTERGREENImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 49781-025-12355 mL in 1 BOTTLE; Type 0: Not a Combination Product10/28/199411/30/2019
2NDC: 49781-025-08237 mL in 1 BOTTLE; Type 0: Not a Combination Product04/15/199011/30/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33504/15/199011/30/2019
Labeler - Cardinal Health (097537435)

Revised: 12/2018
Document Id: 91536e06-5e2b-40b4-aa46-6410dbd99d17
Set id: c90d9a0c-d142-4aba-9459-2de0aca40dbc
Version: 4
Effective Time: 20181212
 
Cardinal Health