PEP TUM- bismuth subsalicylate tablet, chewable

Pep Tum by

Drug Labeling and Warnings

Pep Tum by is a Otc medication manufactured, distributed, or labeled by First Aid Direct. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

PEP TUM 
bismuth subsalicylate tablet, chewable

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (SALICYLIC ACID - UNII:O414PZ4LPZ)	BISMUTH SUBSALICYLATE	262 mg

Inactive Ingredients
Ingredient Name	Strength
ASPARTAME (UNII: Z0H242BBR1)
CALCIUM CARBONATE (UNII: H0G9379FGK)
D&C RED NO. 27 (UNII: 2LRS185U6K)
DEXTRATES (UNII: G263MI44RU)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53117-046-85	30 in 1 CARTON	12/23/2014
1		1 in 1 CELLO PACK; Type 0: Not a Combination Product

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)