Bismatrol

Bismatrol
SPL v7
SPL
SPL Set ID a266f599-2f2c-416f-9ef9-a1d3db552c89
Route
ORAL
Published
Effective Date 2021-01-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Bismuth Cation (262 mg)
Inactive Ingredients
Benzoic Acid D&c Red No. 22 D&c Red No. 28 Hydroxyethyl Cellulose (2000 Cps At 1%) Potassium Hydroxide Water Saccharin Sodium Salicylic Acid Dimethicone Xanthan Gum

Identifiers & Packaging

Pill Appearance
Color: pink
Marketing Status
OTC MONOGRAPH FINAL Active Since 2008-05-30

Description

Bismuth subsalicylate 262 mg

Purpose

Upset stomach reliever and anti-diarrheal


Medication Information

Purpose

Upset stomach reliever and anti-diarrheal

Description

Bismuth subsalicylate 262 mg

Uses

relieves:

  • diarrhea
  • heartburn
  • indigestion
  • nausea
  • upset stomach associated with these symptoms
Section 50565-1


Warnings

Children and teenagers who have or are recovering from children 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. Reye's syndrome:

Allergy alert: Contains salicylate. Do not take if you are

  • allergic to salicylates (including aspirin)
  • taking other salicylate products
Directions
  • shake well before use
  • for accurate dosing, use dose cup
  • adults and children 12 years and over: 1 dose (2 tbsp or 30 mL) every 1/2 to 1 hour as needed
  • do not exceed 8 doses (16 tbsp or 240 mL) in 24 hours
  • use until diarrhea stops but not more than 2 days
  • children under 12 years: ask a doctor
  • drink plenty of clear fluids to help prevent dehydration caused by diarrhea

Other Information
  • each Tbsp contains: sodium 5 mg, salicylate 130 mg, potassium 15 mg
  • protect from freezing
  • avoid excessive heat (over 104 F or 40 C) o o
  • . TAMPER EVIDENT: Do not use if imprinted shrinkband is missing or broken

Inactive Ingredients

benzoic acid, D and C red 22, D and C red 28, flavor, hydroxy ethyl cellulose, potassium hydroxide, purified water, saccharin sodium, salicylic acid, simethicone, xanthan gum.

Do Not Use If You Have
  • bloody or black stool
  • an ulcer
  • a bleeding problem

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 more than 2 days

Ask A Doctor Before Use If You Have
  • fever
  • mucus in the stool

Active Ingredient (in Each 15 Ml Tbsp)

Bismuth subsalicylate 262 mg

Bismatrol (bismuth Subsalicylate) Liquid

Ask A Doctor Or Pharmacist Before Use If You Aretaking Any Drug For
  • anticoagulation (thinning of the blood)
  • diabetes
  • gout
  • arthritis

If Pregnant Or Breast Feeding, Ask A Health Professional Before Use. Keep Out of Reach of Children.

In case of overdose, get medical help or contact a Poison control center  immediately.


Structured Label Content

Uses

relieves:

  • diarrhea
  • heartburn
  • indigestion
  • nausea
  • upset stomach associated with these symptoms
Section 50565-1 (50565-1)


Purpose

Upset stomach reliever and anti-diarrheal

Warnings

Children and teenagers who have or are recovering from children 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. Reye's syndrome:

Allergy alert: Contains salicylate. Do not take if you are

  • allergic to salicylates (including aspirin)
  • taking other salicylate products
Directions
  • shake well before use
  • for accurate dosing, use dose cup
  • adults and children 12 years and over: 1 dose (2 tbsp or 30 mL) every 1/2 to 1 hour as needed
  • do not exceed 8 doses (16 tbsp or 240 mL) in 24 hours
  • use until diarrhea stops but not more than 2 days
  • children under 12 years: ask a doctor
  • drink plenty of clear fluids to help prevent dehydration caused by diarrhea

Other Information (Other information)
  • each Tbsp contains: sodium 5 mg, salicylate 130 mg, potassium 15 mg
  • protect from freezing
  • avoid excessive heat (over 104 F or 40 C) o o
  • . TAMPER EVIDENT: Do not use if imprinted shrinkband is missing or broken

Inactive Ingredients (Inactive ingredients)

benzoic acid, D and C red 22, D and C red 28, flavor, hydroxy ethyl cellulose, potassium hydroxide, purified water, saccharin sodium, salicylic acid, simethicone, xanthan gum.

Do Not Use If You Have (Do not use if you have)
  • bloody or black stool
  • an ulcer
  • a bleeding problem

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 more than 2 days

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • fever
  • mucus in the stool

Active Ingredient (in Each 15 Ml Tbsp) (Active ingredient (in each 15 mL tbsp))

Bismuth subsalicylate 262 mg

Bismatrol (bismuth Subsalicylate) Liquid (BISMATROL (BISMUTH SUBSALICYLATE) LIQUID)

Ask A Doctor Or Pharmacist Before Use If You Aretaking Any Drug For (Ask a doctor or pharmacist before use if you aretaking any drug for)
  • anticoagulation (thinning of the blood)
  • diabetes
  • gout
  • arthritis

If Pregnant Or Breast Feeding, Ask A Health Professional Before Use. Keep Out of Reach of Children. (If pregnant or breast feeding, ask a health professional before use. Keep out of reach of children.)

In case of overdose, get medical help or contact a Poison control center  immediately.


Advanced Ingredient Data


Raw Label Data

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