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

Purpose

Antidiarrheal/Antacid

Description

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


Medication Information

Active Ingredient

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
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

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

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 102 mg salicylate)

Allergy Alert

Contains salicylate. Do not take if you are

  • allergic to salicylates (including aspirin)
  • taking other salicylate products
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.

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.

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

Active Ingredient (Active ingredient (in each tablet))

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
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

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

Inactive Ingredients

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

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

Allergy Alert (Allergy alert)

Contains salicylate. Do not take if you are

  • allergic to salicylates (including aspirin)
  • taking other salicylate products
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.

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.

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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