Leader Stomach Relief original strength

Dosage form: tablet, chewable
Ingredients: BISMUTH SUBSALICYLATE 262mg
Labeler: Cardinal Health
NDC Code: 37205-720

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.

Cardinal Health Stomach Relief Chewables Drug Facts

Active ingredient (in each tablet)

Bismuth subsalicylate 262 mg

Purpose

Upset stomach reliever/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
  • kidney stones
  • a calcium-restricted diet

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. (1-800-222-1222)

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 over: 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: calcium 265 mg and salicylate 99 mg
  • store at 20°-25C°C (68°F-77°F)

Inactive ingredients

calcium carbonate, D&C red #27 aluminum lake, FD&C blue #1 aluminum lake, flavor, magnesium stearate, mannitol, saccharin sodium

Questions?

1-800-719-9260

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Compare to Pepto-Bismol® Chewable Tablets active ingredient

ORIGINAL STRENGTH

Stomach Relief Chewables

Antidiarrheal/Upset Stomach Reliever

Bismuth Subsalicylate 262 mg

Protective Coating Action

Soothing Relief for 5 Symptoms:

Indigestion

Upset Stomach

Nausea

Diarrhea

Heartburn

Stomach Relief Chewables Carton Image 1

Stomach Relief Chewables Carton Image 2

LEADER STOMACH RELIEF  ORIGINAL STRENGTH
bismuth subsalicylate tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37205-720
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BISMUTH SUBSALICYLATE (BISMUTH SUBSALICYLATE) BISMUTH SUBSALICYLATE262 mg
Inactive Ingredients
Ingredient NameStrength
CALCIUM CARBONATE 
MAGNESIUM STEARATE 
MANNITOL 
SACCHARIN SODIUM 
Product Characteristics
ColorPINKScoreno score
ShapeROUNDSize17mm
FlavorImprint CodeL469
Contains    
Packaging
#Item CodePackage Description
1NDC:37205-720-655 BLISTER PACK (BLISTER PACK) in 1 CARTON
16 TABLET, CHEWABLE (TABLET) in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33510/07/1997
Labeler - Cardinal Health (097537435)

Revised: 01/2012
 
Cardinal Health

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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