Drug Facts

Drug Facts
SPL v8
SPL
SPL Set ID e4b1929c-0967-44ea-8552-6549aa2a464e
Route
ORAL
Published
Effective Date 2018-12-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Bismuth Cation (262 mg)
Inactive Ingredients
Acacia Aspartame Calcium Carbonate D&c Red No. 27 Dextrates Magnesium Stearate Maltodextrin Microcrystalline Cellulose Silicon Dioxide 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 12 years and over: 2 tablets every ½ to 1 hour as needed

  • do not exceed 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
Active Ingredient

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

Other Information
  • Phenylketonurics: contains phenylalanine 1.1mg per tablet
  • Calcium content per tablet: 73mg
  • save carton for full directions and warnings
  • store at room temperature  15°– 30°C (59°– 86°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
  • 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
  • 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. 

Ask A Doctor Before Use If You Have
  • fever
  • mucus in the stool
Package/label Principal Display Panel

Stomach Relief


Ask A Doctor Or Pharmacist Before Use If

you are taking any drug for

  • anticoagulation (thinning of 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 every ½ to 1 hour as needed

  • do not exceed 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
Active Ingredient (Active ingredient)

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

Other Information (Other information)
  • Phenylketonurics: contains phenylalanine 1.1mg per tablet
  • Calcium content per tablet: 73mg
  • save carton for full directions and warnings
  • store at room temperature  15°– 30°C (59°– 86°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 (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
  • 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 (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. 

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)

Stomach Relief


Ask A Doctor Or Pharmacist Before Use If (Ask a doctor or pharmacist before use if)

you are taking any drug for

  • anticoagulation (thinning of the blood)    
  • diabetes
  • gout
  • arthritis

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)