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Leader Stomach Relief by Cardinal Health

Medically reviewed by Drugs.com. Last updated on Jun 6, 2019.

Dosage form: tablet, chewable
Ingredients: BISMUTH SUBSALICYLATE 262mg
Labeler: Cardinal Health
NDC Code: 70000-0433

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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:


  • diarrhea
  • heartburn
  • indigestion
  • nausea
  • upset stomach associated with these symptoms

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 behaviour 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 of 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 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 in mouth
  • adults and children 12 years and over: 2 tablets every 1/2 to 1 hour as needed
  • do not take more than 8 doses (16 tablets) in 24 hours
  • use until diarrhea stops but not more than 2 days
  • children under 12 years: ask a doctor
  • drink plenty of fluids to help prevent dehydration which may accompany diarrhea

OTHER INFORMATION
  • each tablet contains:
  • sodium less than 1 mg
  • salicylate 102 mg
  • very low sodium
  • avoid excessive heat (over 104oF or 40oC)
  • TAMPER EVIDENT: Do not use if individual compartments are torn or open

INACTIVE INGREDIENTS

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

PRINCIPAL DISPLAY PANEL

NDC 70000-0433-2
LEADER

Stomach Relief
Bismuth Subsalicylate 262 mg
Upset Stomach Reliever/Antidiarrheal

5 Symptom Digestive Relief

  • Diarrhea
  • Heartburn
  • Indigestion
  • Nausea
  • Upset stomach

COMPATE TO PEPTO-BISMOL® active ingredient*

48 CHEWABLE TABLETS




LEADER STOMACH RELIEF 
bismuth subsalicylate tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0433
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BISMUTH SUBSALICYLATE (SALICYLIC ACID) BISMUTH SUBSALICYLATE262 mg
Inactive Ingredients
Ingredient NameStrength
CALCIUM CARBONATE 
D&C RED NO. 27 
MAGNESIUM STEARATE 
MANNITOL 
STARCH, CORN 
SACCHARIN SODIUM 
Product Characteristics
ColorPINKScoreno score
ShapeROUNDSize17mm
FlavorImprint CodeGDC122
Contains    
Packaging
#Item CodePackage Description
1NDC:70000-0433-28 BLISTER PACK in 1 BOX
16 TABLET, CHEWABLE in 1 BLISTER PACK
2NDC:70000-0433-15 BLISTER PACK in 1 BOX
26 TABLET, CHEWABLE in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33506/06/2019
Labeler - Cardinal Health (097537435)

 
Cardinal Health

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