Bismuth Subsalicylate 262 Mg

Bismuth Subsalicylate 262 Mg
SPL v1
SPL
SPL Set ID 308f4b2a-22ff-42b9-e063-6394a90acc75
Route
ORAL
Published
Effective Date 2025-03-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Bismuth Cation (262 mg)
Inactive Ingredients
Sucrose

Identifiers & Packaging

Pill Appearance
Imprint: SR Shape: round Color: pink Size: 19 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-03-17

Description

Active ingredient (in each chewable tablet) Bismuth subsalicylate 262 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 the 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 rear but serious illness.

Indications and Usage

Uses relieves

  • Traveler's diarrhea
  • Diarrhea
  • Upset stomach due to overindulgence in food or drink, ingluding
  • Heartburn
  • Indigestion
  • Nausea
  • Gas
  • Belching
  • Fullness
Dosage and Administration

Directions

  • Fully chew before swallowing
  • Adults and children 12 years and over:
  • 2 chewable tablets every 1/2 hour or 4 chewable tablets every hour as needed for diarrhea
  • 2 chewable tablets every 1/2 hour to 1 hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea).
  • Do not exceed 8 doses (16 chewable tablets) 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.
Description

Active ingredient (in each chewable tablet) Bismuth subsalicylate 262 mg

Section 34088-5

In case of overdose, get medical help or contact a Poison Control Center right away.

Section 50565-1

Keep out of reach of children.

Section 50566-9

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
Section 50567-7

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

Section 50568-5

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

  • Anticoagulation (thinning the blood)
  • Diabetes
  • Gout
  • Arthritis
Section 50569-3

Ask a doctor before use if you have

  • Fever
  • Mucus in the stool
Section 50570-1

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

  • Allergic to salicylates (including aspirin)
  • taking other salicylate products
Section 51727-6

Inactive ingredients: Beeswax, calcium carbonate, carmine, carnauba wax, citric acid, corn starch, corn syrup, dextrin, ethyl acetate, FD&C blue no 1 aluminum lake, FD&C blue no. 2 aluminum lake, FD&C red no. 40 aluminum lake, FD&C yellow no. 6 aluminum lake, glycerin, gum arabic, hydrogenated coconut oil, maltodextrin, medium chain triglycerides, natural and artificial flavors, phosphoric acid, propylene glycol, shellac, sodium benzoate, sorbic acid, sorbitol, soy lecithin, soybean oil, sucrose, titanium dioxide, vegetable oil (coconut and/or canola oil), water.

Section 51945-4

Section 53413-1

Questions? Call 1-800-245-2989 Mon - Fri, 9AM - 4PM EST

Section 53414-9

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

Section 55105-1

Purpose

Upset stomachreliever and antidiarrheal

Section 55106-9

Active ingredient (in each chewable tablet)

Bismuth subsalicylate 262 mg

Section 60561-8

Other information

  • Each chewable tablet contains: Calcium 50 mg
  • Salicylate 123 mg
  • Contains soy
  • Store between 20° to 25°C (68° to 77°F) in a dry place. Avoid excessive heat (over 40°C).

Structured Label Content

Indications and Usage (34067-9)

Uses relieves

  • Traveler's diarrhea
  • Diarrhea
  • Upset stomach due to overindulgence in food or drink, ingluding
  • Heartburn
  • Indigestion
  • Nausea
  • Gas
  • Belching
  • Fullness
Dosage and Administration (34068-7)

Directions

  • Fully chew before swallowing
  • Adults and children 12 years and over:
  • 2 chewable tablets every 1/2 hour or 4 chewable tablets every hour as needed for diarrhea
  • 2 chewable tablets every 1/2 hour to 1 hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea).
  • Do not exceed 8 doses (16 chewable tablets) 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.
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 the 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 rear but serious illness.

Section 34088-5 (34088-5)

In case of overdose, get medical help or contact a Poison Control Center right away.

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50566-9 (50566-9)

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
Section 50567-7 (50567-7)

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

Section 50568-5 (50568-5)

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

  • Anticoagulation (thinning the blood)
  • Diabetes
  • Gout
  • Arthritis
Section 50569-3 (50569-3)

Ask a doctor before use if you have

  • Fever
  • Mucus in the stool
Section 50570-1 (50570-1)

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

  • Allergic to salicylates (including aspirin)
  • taking other salicylate products
Section 51727-6 (51727-6)

Inactive ingredients: Beeswax, calcium carbonate, carmine, carnauba wax, citric acid, corn starch, corn syrup, dextrin, ethyl acetate, FD&C blue no 1 aluminum lake, FD&C blue no. 2 aluminum lake, FD&C red no. 40 aluminum lake, FD&C yellow no. 6 aluminum lake, glycerin, gum arabic, hydrogenated coconut oil, maltodextrin, medium chain triglycerides, natural and artificial flavors, phosphoric acid, propylene glycol, shellac, sodium benzoate, sorbic acid, sorbitol, soy lecithin, soybean oil, sucrose, titanium dioxide, vegetable oil (coconut and/or canola oil), water.

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions? Call 1-800-245-2989 Mon - Fri, 9AM - 4PM EST

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Purpose

Upset stomachreliever and antidiarrheal

Section 55106-9 (55106-9)

Active ingredient (in each chewable tablet)

Bismuth subsalicylate 262 mg

Section 60561-8 (60561-8)

Other information

  • Each chewable tablet contains: Calcium 50 mg
  • Salicylate 123 mg
  • Contains soy
  • Store between 20° to 25°C (68° to 77°F) in a dry place. Avoid excessive heat (over 40°C).

Advanced Ingredient Data


Raw Label Data

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