046 - Bismuth

046 - Bismuth
SPL v7
SPL
SPL Set ID cdfcfdc2-ed5e-49d8-b16f-e32748d82e3e
Route
ORAL
Published
Effective Date 2016-12-19
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 Maltodextrin Microcrystalline Cellulose Silicon Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: RH;046 Shape: round Color: pink Size: 17 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2003-04-28

Description

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

Purpose

Antidiarrheal/Antacid


Medication Information

Purpose

Antidiarrheal/Antacid

Description

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

Uses

■ controls diarrhea   

■ relieves heartburn, indigestion, nausea and upset stomach

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 occur, 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 salicylates (including aspirin) 

■ taking other salicylate products

Directions

■ drink plenty of clear fluids to help revent deydration caused by diarrhea 

■ Adults and children 12 years and over: 2 tablets every ½ to 1 hour or 4 tablets every hour as needed

■ do not exceed 16 tablets in 24 hours  

■ use until diarrhea stops but no more than 2 days 

■ Children under 12 years of age: ask a doctor

Active Ingredient

 Bismuth subsalicylate 262mg (each tablet contains 102mg 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

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

Pregnancy/breastfeeding

ask a health professional before use.

Principal Display Panel

Bismuth
 

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 for more than 2 days

Keep Out of Reach of Children

In case of accidental overdose, contact a doctor or Poison Control Center (1-800-222-1222) immediately.

Ask A Doctor Before Use If You Have

■ fever   

■ mucus in the stool

Ask A Doctor Or Pharmacist Before Use If

you are taking a drug for  

■ anticoagulation (thinning of the blood)   

■ diabetes   

■ gout   

■ arthritis


Structured Label Content

Uses

■ controls diarrhea   

■ relieves heartburn, indigestion, nausea and upset stomach

Purpose

Antidiarrheal/Antacid

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 occur, 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 salicylates (including aspirin) 

■ taking other salicylate products

Directions

■ drink plenty of clear fluids to help revent deydration caused by diarrhea 

■ Adults and children 12 years and over: 2 tablets every ½ to 1 hour or 4 tablets every hour as needed

■ do not exceed 16 tablets in 24 hours  

■ use until diarrhea stops but no more than 2 days 

■ Children under 12 years of age: ask a doctor

Active Ingredient (Active ingredient)

 Bismuth subsalicylate 262mg (each tablet contains 102mg 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

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)

■ bloody or black stool  

■ an ulcer 

■ a bleeding problem

Pregnancy/breastfeeding (Pregnancy/Breastfeeding)

ask a health professional before use.

Principal Display Panel

Bismuth
 

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 for more than 2 days

Keep Out of Reach of Children (Keep out of reach of children)

In case of accidental overdose, contact a doctor or Poison Control Center (1-800-222-1222) immediately.

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

■ fever   

■ mucus in the stool

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

you are taking a drug for  

■ anticoagulation (thinning of the blood)   

■ diabetes   

■ gout   

■ arthritis


Advanced Ingredient Data


Raw Label Data

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