Drug Facts

Drug Facts
SPL v7
SPL
SPL Set ID 015ca07a-f6b5-4741-a7b0-821cf6d4e418
Route
ORAL
Published
Effective Date 2018-11-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Bismuth Cation (262 mg)
Inactive Ingredients
Aspartame Calcium Carbonate D&c Red No. 27 Dextrates Magnesium Stearate Cellulose, Microcrystalline Silicon Dioxide Acacia Maltodextrin Peppermint

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 over 12 years : 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 no more than 2 days

Children under 12 years of age: ask a doctor

  • drink plenty of clear fluids to prevent dehydration caused by diarrhea 
Allergy Alert

Contains salicylate. Do not take if you are allergic to salicylates (including aspirin) taking other salicylate products

Active Ingredient

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

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
  • an ulcer
  • a bleeding problem
  • bloody or black stool
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 or last more than 2 days   
  • ringing in the ears or loss of hearing occurs  n 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, contact a doctor or Poison Control Center (1-800-222-1222) right away. 

Ask A Doctor Before Use If You Have
  • fever
  • mucus in the stool
Package/label Principal Display Panel
Bismuth
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 over 12 years : 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 no more than 2 days

Children under 12 years of age: ask a doctor

  • drink plenty of clear fluids to 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

Active Ingredient (Active ingredient)

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

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)
  • an ulcer
  • a bleeding problem
  • bloody or black stool
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 or last more than 2 days   
  • ringing in the ears or loss of hearing occurs  n 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, contact a doctor or Poison Control Center (1-800-222-1222) right away. 

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • fever
  • mucus in the stool
Package/label Principal Display Panel (Package/Label Principal Display Panel)
Bismuth
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

All Sections (JSON)