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Pep Tum

Dosage form: tablet, chewable
Ingredients: BISMUTH SUBSALICYLATE 262mg
Labeler: First Aid Direct
NDC code: 53117-046

Medically reviewed by Drugs.com. Last updated on Dec 12, 2022.

Drug Facts

Active ingredient (in each tablet)

Bismuth subsalicylate 262 mg (each tablet contains 102 mg salicylate)

Purpose

Antidiarrheal/Antacid

Uses
  • controls diarrhea
  • relieves heartburn, indigestion, nausea and upset stomach without constipating

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

Ask a doctor or pharmacist before use if you
  • are taking any drug for anticoagulation (thinning the blood)
  • diabetes
  • gout
  • arthritis

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

When using this product

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

If pregnant or breast-feeding,

ask a health professional before use.

Keep Out of Reach of Children.

In case of accidental overdose, contact a doctor or Poison Control Center immediately.

Directions
  • drink plenty of clear fluids to help prevent dehydration caused by diarrhea 
  • Adults and Children 12 years and over: 525 mg (2 tablets) every ½ to 1 hour or 1050 mg (4 tablets) every hour as needed
    • do not exceed 4200 mg ( 16 tablets) in 24 hours
    • use until diarrhea stops but not more than 2 days 
  • Children under 12 years: ask a doctor

Inactive Ingredients

aspartame, calcium carbonate, , D&C red #27, dextrates, flavor, magnesium stearate, microcrystalline cellulose, silicon dioxide

Package/Label Principal Display Panel

Pep Tum

PEP TUM 
bismuth subsalicylate tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53117-046
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BISMUTH SUBSALICYLATE (SALICYLIC ACID) BISMUTH SUBSALICYLATE262 mg
Inactive Ingredients
Ingredient NameStrength
ASPARTAME 
CALCIUM CARBONATE 
D&C RED NO. 27 
DEXTRATES 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
SILICON DIOXIDE 
Product Characteristics
ColorPINKScoreno score
ShapeROUNDSize17mm
FlavorImprint CodeRH046
Contains    
Packaging
#Item CodePackage Description
1NDC:53117-046-8530 CELLO PACK in 1 CARTON
11 TABLET, CHEWABLE in 1 CELLO PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33512/23/2014
Labeler - First Aid Direct (962283128)

Document Id: e54bc57c-ffd9-48d6-ae67-0136f31aa91e
Set id: bf966e9f-2f95-41cd-a6e5-b8eb521181d8
Version: 6
Effective Time: 20171222
 
First Aid Direct

Further information

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

Medical Disclaimer