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

Purpose

Antidiarrheal/Antacid

Description

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


Medication Information

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
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 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
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.

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
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

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.

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

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