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, 2023.

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 Type	HUMAN OTC DRUG	Item Code (Source)	NDC:53117-046
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BISMUTH SUBSALICYLATE (SALICYLIC ACID)	BISMUTH SUBSALICYLATE	262 mg

Inactive Ingredients
Ingredient Name	Strength
ASPARTAME
CALCIUM CARBONATE
D&C RED NO. 27
DEXTRATES
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
SILICON DIOXIDE

Product Characteristics
Color	PINK	Score	no score
Shape	ROUND	Size	17mm
Flavor		Imprint Code	RH046
Contains

Packaging
#	Item Code	Package Description
1	NDC:53117-046-85	30 CELLO PACK in 1 CARTON
1		1 TABLET, CHEWABLE in 1 CELLO PACK

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part335	12/23/2014

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