Bismutina

Bismutina
SPL v3
SPL
SPL Set ID 14bbbdbb-87c8-47a9-9147-7e0f1b75c7b9
Route
ORAL
Published
Effective Date 2021-04-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (525 mg)
Inactive Ingredients
Benzoic Acid Anhydrous Citric Acid Fd&c Yellow No. 5 Salicylic Acid Sodium Citrate Sodium Salicylate Sorbic Acid Sucralose Water Xanthan Gum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-04-01

Description

Active Ingredients Bismuth Subsalicylate 525 mg


Medication Information

Warnings and Precautions

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 there 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

Do not use if you have 

  • an ulcer
  • a bleeding problem
  • bloody or black stool

Ask a doctor before use if you have 

  • fever
  • mucus in the stool

Ask a doctor or pharmacist before use if you are taking any drug for 

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

When using this product, a temporary, but harmless, darking of the stool and/or tongue may occur.

Stop use and ask a doctor if

  • symptoms get worse or last for more than two days
  • ringing in the ears or loss of hearing occurs
  • diarrhea lasts more than 2 days
Indications and Usage

Uses

relieves

  • traveler's diarrhea
  • diarrhea
  • upset stomach due to overindulgence in food and drink, including:
  • heartburn
  • indigestion
  • nausea
  • gas
  • belching
Dosage and Administration

Directions

  • drink plenty of clear fluids to help prevent dehydration cause by diarrhea
  • shake well before use
  • adults and children 12 years of age and over:
  • 2 tablespoonfuls (30 mL) every 1/2 hour or 4 tablespoonfuls (60 mL) every hour as needed for diarrhea/traveler's diarrhea  
  • 2 tablespoonfuls (30 mL) every 1/2 hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea)
  • do not exceed 8 doses (16 tablesproonfuls or 240 mL) in 24 hours
  • use until diarrhea stops but not more than 2 days
  • Children under 12 years: ask a doctor
Description

Active Ingredients Bismuth Subsalicylate 525 mg

Section 50565-1

Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away.

Section 51727-6

Inactive ingredients

benzoic acid, citric acid, FD&C yellow #5, flavor, salicylic acid, sodium citrate, sodium salicylate, sorbic acid, sucralose, water, xanthan gum

Section 51945-4

Section 53413-1

Questions? call 1-800-560-5223 M-F 9 AM to 5 PM Eastern Time

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1

Purpose

Upset Stomach Reliever and Antidiarrheal

Section 55106-9

Active Ingredients

Bismuth Subsalicylate 525 mg


Structured Label Content

Indications and Usage (34067-9)

Uses

relieves

  • traveler's diarrhea
  • diarrhea
  • upset stomach due to overindulgence in food and drink, including:
  • heartburn
  • indigestion
  • nausea
  • gas
  • belching
Dosage and Administration (34068-7)

Directions

  • drink plenty of clear fluids to help prevent dehydration cause by diarrhea
  • shake well before use
  • adults and children 12 years of age and over:
  • 2 tablespoonfuls (30 mL) every 1/2 hour or 4 tablespoonfuls (60 mL) every hour as needed for diarrhea/traveler's diarrhea  
  • 2 tablespoonfuls (30 mL) every 1/2 hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea)
  • do not exceed 8 doses (16 tablesproonfuls or 240 mL) in 24 hours
  • use until diarrhea stops but not more than 2 days
  • Children under 12 years: ask a doctor
Warnings and Precautions (34071-1)

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 there 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

Do not use if you have 

  • an ulcer
  • a bleeding problem
  • bloody or black stool

Ask a doctor before use if you have 

  • fever
  • mucus in the stool

Ask a doctor or pharmacist before use if you are taking any drug for 

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

When using this product, a temporary, but harmless, darking of the stool and/or tongue may occur.

Stop use and ask a doctor if

  • symptoms get worse or last for more than two days
  • ringing in the ears or loss of hearing occurs
  • diarrhea lasts more than 2 days
Section 50565-1 (50565-1)

Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away.

Section 51727-6 (51727-6)

Inactive ingredients

benzoic acid, citric acid, FD&C yellow #5, flavor, salicylic acid, sodium citrate, sodium salicylate, sorbic acid, sucralose, water, xanthan gum

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions? call 1-800-560-5223 M-F 9 AM to 5 PM Eastern Time

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1 (55105-1)

Purpose

Upset Stomach Reliever and Antidiarrheal

Section 55106-9 (55106-9)

Active Ingredients

Bismuth Subsalicylate 525 mg


Advanced Ingredient Data


Raw Label Data

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