dd14cd57-3f7c-4634-9da9-6f83dc5bae12

SPL v13
SPL
SPL Set ID dd14cd57-3f7c-4634-9da9-6f83dc5bae12
Route
oral
Published
Effective Date 2025-09-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
salicylic acid (262 mg)
Inactive Ingredients
acacia aspartame calcium carbonate d&c red no. 27 aluminum lake dextrates magnesium stearate maltodextrin microcrystalline cellulose peppermint silicon dioxide

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2021-10-25

Purpose

Antidiarrheal/Antacid

Description

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


Medication Information

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 occurs, 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 salicylate (including asprin)
  • taking other salicylate products
Active Ingredient

Bismuth subsalicylate 262 mg

(each tablet contains 102mg salicylate)

Uses

relieves

  • travelers' diarrhea
  • diarrhea
  • upset stomach due to overindulgence in food and drink including:
  • heartburn
  • indigestion
  • nausea
  • gas
  • belching
  • fullness
Purpose

Antidiarrheal/Antacid

Directions
  • chew or dissolve in mouth
  • Adults and children 12 years and over: 2 tablets (1 dose) every ½ hour or 4 tablets (2 doses) every hour as needed for diarrhea
  • 2 tablets (1 dose) every 1/2 hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea)
  • do not exceed 8 doses (16 tablets) in 24 hours
  • use until diarrhea stops but not more than 2 days
  • Children under 12: ask a doctor
  • drink plenty of fluids to help prevent dehydration which may accompany diarrhea
Other Information
  • Phenylketonurics: contains phenylalanine 1.1 mg per tablet

Calcium content per tablet: 73mg

  • store at room temperature 15° - 30°C (59° - 86°F)
  • avoid excessive heat (over 40°C or 104°F)
  • do not use if cellophane unit is torn

Inactive Ingredients

acacia gum, aspartame, calcium carbonate, D&C red #27 aluminum lake, dextrates, magnesium stearate, maltodextrin, microcrystalline cellulose, peppermint flavor, silicon dioxide

Description

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

Questions?

1-800-327-2704  Monday-Friday 8:00am - 5:00pm (CDT)

Section 50565-1

Keep out of reach of children. ​In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Section 50566-9

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

Section 50567-7

When using this product ​a temporary, but harmless darkening of the stool and/or tongue may occur

Section 50568-5

Ask a doctor or pharmacist before use if you are ​taking any drug for

  • anticoagulation (thinning of the blood)
  • diabetes
  • gout
  • arthritis
Section 50569-3

Ask a doctor before use if you have

  • ​​fever
  • mucus in stool
Section 50570-1

Do not use if you have

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

Section 53414-9

If pregnant or breast-feeding, ​ask a health professional before use.

Principal Display Panel Box

Pep Tum ​™

Bismuth subsalicylate

COMPARE ACTIVE INGREDIENTS TO PEPTO-BISMOL®*

262 mg

SOOTHING RELIEF FOR:

  • Upset Stomach
  • Diarrhea
  • Heartburn
  • Indigestion
  • Nausea

30 Chewable Tablets


Structured Label Content

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 occurs, 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 salicylate (including asprin)
  • taking other salicylate products
Active Ingredient (Active ingredient (in each tablet))

Bismuth subsalicylate 262 mg

(each tablet contains 102mg salicylate)

Uses

relieves

  • travelers' diarrhea
  • diarrhea
  • upset stomach due to overindulgence in food and drink including:
  • heartburn
  • indigestion
  • nausea
  • gas
  • belching
  • fullness
Purpose

Antidiarrheal/Antacid

Directions
  • chew or dissolve in mouth
  • Adults and children 12 years and over: 2 tablets (1 dose) every ½ hour or 4 tablets (2 doses) every hour as needed for diarrhea
  • 2 tablets (1 dose) every 1/2 hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea)
  • do not exceed 8 doses (16 tablets) in 24 hours
  • use until diarrhea stops but not more than 2 days
  • Children under 12: ask a doctor
  • drink plenty of fluids to help prevent dehydration which may accompany diarrhea
Other Information (Other information)
  • Phenylketonurics: contains phenylalanine 1.1 mg per tablet

Calcium content per tablet: 73mg

  • store at room temperature 15° - 30°C (59° - 86°F)
  • avoid excessive heat (over 40°C or 104°F)
  • do not use if cellophane unit is torn

Inactive Ingredients (Inactive ingredients)

acacia gum, aspartame, calcium carbonate, D&C red #27 aluminum lake, dextrates, magnesium stearate, maltodextrin, microcrystalline cellulose, peppermint flavor, silicon dioxide

Questions?

1-800-327-2704  Monday-Friday 8:00am - 5:00pm (CDT)

Section 50565-1 (50565-1)

Keep out of reach of children. ​In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Section 50566-9 (50566-9)

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

Section 50567-7 (50567-7)

When using this product ​a temporary, but harmless darkening of the stool and/or tongue may occur

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are ​taking any drug for

  • anticoagulation (thinning of the blood)
  • diabetes
  • gout
  • arthritis
Section 50569-3 (50569-3)

Ask a doctor before use if you have

  • ​​fever
  • mucus in stool
Section 50570-1 (50570-1)

Do not use if you have

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

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ​ask a health professional before use.

Principal Display Panel Box (Principal Display Panel - Box)

Pep Tum ​™

Bismuth subsalicylate

COMPARE ACTIVE INGREDIENTS TO PEPTO-BISMOL®*

262 mg

SOOTHING RELIEF FOR:

  • Upset Stomach
  • Diarrhea
  • Heartburn
  • Indigestion
  • Nausea

30 Chewable Tablets


Advanced Ingredient Data


Raw Label Data

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