Drug Facts

Drug Facts
SPL v8
SPL
SPL Set ID bf966e9f-2f95-41cd-a6e5-b8eb521181d8
Route
ORAL
Published
Effective Date 2017-12-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (262 mg)
Inactive Ingredients
Aspartame Calcium Carbonate D&c Red No. 27 Dextrates Magnesium Stearate Cellulose, Microcrystalline Silicon Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: RH046 Shape: round Color: pink Size: 17 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2014-12-23

Description

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

Purpose

Antidiarrheal/Antacid


Medication Information

Purpose

Antidiarrheal/Antacid

Description

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

Uses

relieves

  • travelers’ diarrhea
  • diarrhea
  • upset stomach due to overindulgence in food and drink including:
  • heartburn
  • indigestion
  • nausea
  • gas
  • belching
  • fullness
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 years of age: ask a doctor
  • drink plenty of clear fluids to help prevent dehydration caused by diarrhea

Allergy Alert

Contains salicylate. Do not take if you are

  • allergic to salicylates (including aspirin)
  • taking other salicylate products
Other Information
  • Phenylketonurics: contains phenylalanine 1.1mg 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

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.

Inactive Ingredients

acacia gum, aspartame, calcium carbonate, D&C red #27 aluminum lake, dextrates,

magnesium stearate, maltodextrin, microcrystalline cellulose, peppermint flavor, silicon dioxide

Do Not Use If You Have
  • bloody or black stool
  • an ulcer
  • a bleeding problem
When Using This Product

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

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
If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out of Reach of Children.

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

Active Ingredient (in Each Tablet)

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

Package/label Principal Display Panel
Pep Tum
Ask A Doctor Or Pharmacist Before Use If You
  • are taking any drug for anticoagulation (thinning the blood)
  • diabetes
  • gout
  • arthritis

Structured Label Content

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 years of age: ask a doctor
  • drink plenty of clear fluids to help prevent dehydration caused by diarrhea

Allergy Alert (Allergy alert)

Contains salicylate. Do not take if you are

  • allergic to salicylates (including aspirin)
  • taking other salicylate products
Other Information
  • Phenylketonurics: contains phenylalanine 1.1mg 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

Reye’s Syndrome (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.

Inactive Ingredients

acacia gum, aspartame, calcium carbonate, D&C red #27 aluminum lake, dextrates,

magnesium stearate, maltodextrin, microcrystalline cellulose, peppermint flavor, silicon dioxide

Do Not Use If You Have (Do not use if you have)
  • bloody or black stool
  • an ulcer
  • a bleeding problem
When Using This Product (When using this product)

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

Stop Use and Ask A Doctor If (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
If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children.

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

Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))

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

Package/label Principal Display Panel (Package/Label Principal Display Panel)
Pep Tum
Ask A Doctor Or Pharmacist Before Use If You (Ask a doctor or pharmacist before use if you)
  • are taking any drug for anticoagulation (thinning the blood)
  • diabetes
  • gout
  • arthritis

Advanced Ingredient Data


Raw Label Data

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