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

Purpose

Antidiarrheal/Antacid

Description

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


Medication Information

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

Uses

■ controls diarrhea   

■ relieves heartburn, indigestion, nausea and upset stomach

Purpose

Antidiarrheal/Antacid

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

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

Description

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

Principal Display Panel

Bismuth
 

Active Ingredient

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

Do Not Use If You Have

■ bloody or black stool  

■ an ulcer 

■ a bleeding problem

Pregnancy/breastfeeding

ask a health professional before use.

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

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

Uses

■ controls diarrhea   

■ relieves heartburn, indigestion, nausea and upset stomach

Purpose

Antidiarrheal/Antacid

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

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

Principal Display Panel

Bismuth
 

Active Ingredient (Active ingredient)

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

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.

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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