Major Bismuth Subsalicylate

Drug Facts

Composition & Product

Active Ingredients

Salicylic Acid (262 mg)

Inactive Ingredients

Calcium Carbonate D&c Red No. 27 Magnesium Stearate Mannitol Starch, Corn Saccharin Sodium

Identifiers & Packaging

Pill Appearance

Imprint: G122 Shape: round Color: pink Size: 16 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2021-10-11

Medication Information

Purpose

Upset stomach reliever and anti-diarrheal

Description

Bismuth subsalicylate 262 mg (total salicylate 102 mg per tablet)

Use(s)

relieves:

•
diarrhea
•
heartburn
•
indigestion
•
nausea
•
upset stomach associated with these symptoms

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 behaviour 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

Directions

•
chew or dissolve in mouth
•
adults and children 12 years and over: 2 tablets every 1/2 to 1 hour as needed
•
do not take more than 8 doses (16 tablets) in 24 hours
•
children under 12 years: ask a doctor
•
drink plenty of clear fluids to help prevent dehydration caused diarrhea

Other Information

•
each tablet contains:
•
sodium less than 1 mg
•
salicylate 102 mg
•
very low sodium
•
avoid excessive heat (over 104^oF or 40^oC)
•
TAMPER EVIDENT: Do not use if individual compartments are torn on open.

Inactive Ingredients

calcium carbonate, D&C red 27 aluminum lake, flavor, magnesium stearate, mannitol, pregelatinized starch, saccharin sodium

Do Not Use If You Have

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

Principal Display Panel

MAJOR

NDC 68788-8239-3

*Compare to the active ingredient in Pepto-Bismol^®

Bismuth Subsalicylate 262 mg

Upset Stomach Reliever / Anti-diarrheal

Soothing, coating action provides fast relief for

heartburn, indigestion

nausea, upset stomach

and diarrhea

30 Chewable Tablets

Relabeled By: Preferred Pharmaceuticals Inc.

When Using This Product

a temporary, but harmless darkening of the stool and/or tongue may occur

Stop Use and Ask Doctor If

•
symptoms get worse
•
ringing in the ears or loss of hearing occurs
•
diarrhea lasts more than 2 days

Keep Out of Reach of Children

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.

If Pregnant Or Breast Feeding,

ask a health professional before use.

Active Ingredient(in Each Tablet)

Bismuth subsalicylate 262 mg

(total salicylate 102 mg per tablet)

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 of the blood)
•
diabetes
•
gout
•
arthritis

Structured Label Content

Use(s) (USE(S))

relieves:

•
diarrhea
•
heartburn
•
indigestion
•
nausea
•
upset stomach associated with these symptoms

Purpose (PURPOSE)

Upset stomach reliever and anti-diarrheal

Warnings (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 behaviour 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

Directions (DIRECTIONS)

•
chew or dissolve in mouth
•
adults and children 12 years and over: 2 tablets every 1/2 to 1 hour as needed
•
do not take more than 8 doses (16 tablets) in 24 hours
•
children under 12 years: ask a doctor
•
drink plenty of clear fluids to help prevent dehydration caused diarrhea

Other Information (OTHER INFORMATION)

•
each tablet contains:
•
sodium less than 1 mg
•
salicylate 102 mg
•
very low sodium
•
avoid excessive heat (over 104^oF or 40^oC)
•
TAMPER EVIDENT: Do not use if individual compartments are torn on open.

Inactive Ingredients (INACTIVE INGREDIENTS)

calcium carbonate, D&C red 27 aluminum lake, flavor, magnesium stearate, mannitol, pregelatinized starch, saccharin sodium

Do Not Use If You Have (DO NOT USE IF YOU HAVE)

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

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

MAJOR

NDC 68788-8239-3

*Compare to the active ingredient in Pepto-Bismol^®

Bismuth Subsalicylate 262 mg

Upset Stomach Reliever / Anti-diarrheal

Soothing, coating action provides fast relief for

heartburn, indigestion

nausea, upset stomach

and diarrhea

30 Chewable Tablets

Relabeled By: Preferred Pharmaceuticals Inc.

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 Doctor If (STOP USE AND ASK DOCTOR IF)

•
symptoms get worse
•
ringing in the ears or loss of hearing occurs
•
diarrhea lasts more than 2 days

Keep Out of Reach of Children (KEEP OUT OF REACH OF CHILDREN)

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.

If Pregnant Or Breast Feeding, (IF PREGNANT OR BREAST-FEEDING,)

ask a health professional before use.

Active Ingredient(in Each Tablet) (ACTIVE INGREDIENT(in each tablet))

Bismuth subsalicylate 262 mg

(total salicylate 102 mg per tablet)

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 You Are (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

[{"name": "SALICYLIC ACID", "unii": "O414PZ4LPZ", "classCode": "ACTIB", "strengthNumerator": "262", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "CALCIUM CARBONATE", "unii": "H0G9379FGK", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "D&C RED NO. 27", "unii": "2LRS185U6K", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MANNITOL", "unii": "3OWL53L36A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STARCH, CORN", "unii": "O8232NY3SJ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SACCHARIN SODIUM", "unii": "SB8ZUX40TY", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"USE(S)": "relieves: • diarrhea • heartburn • indigestion • nausea • upset stomach associated with these symptoms", "PURPOSE": "Upset stomach reliever and anti-diarrheal", "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 behaviour 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", "DIRECTIONS": "• chew or dissolve in mouth • adults and children 12 years and over: 2 tablets every 1/2 to 1 hour as needed • do not take more than 8 doses (16 tablets) in 24 hours • children under 12 years: ask a doctor • drink plenty of clear fluids to help prevent dehydration caused diarrhea", "OTHER INFORMATION": "• each tablet contains: • sodium less than 1 mg • salicylate 102 mg • very low sodium • avoid excessive heat (over 104 o F or 40 o C) • TAMPER EVIDENT: Do not use if individual compartments are torn on open. ", "INACTIVE INGREDIENTS": "calcium carbonate, D&C red 27 aluminum lake, flavor, magnesium stearate, mannitol, pregelatinized starch, saccharin sodium", "DO NOT USE IF YOU HAVE": "• bloody or black stool • an ulcer • a bleeding problem", "PRINCIPAL DISPLAY PANEL": "MAJOR NDC 68788-8239-3 *Compare to the active ingredient in Pepto-Bismol ® Bismuth Subsalicylate 262 mg Upset Stomach Reliever / Anti-diarrheal Soothing, coating action provides fast relief for heartburn, indigestion nausea, upset stomach and diarrhea 30 Chewable Tablets Relabeled By: Preferred Pharmaceuticals Inc.", "WHEN USING THIS PRODUCT": "a temporary, but harmless darkening of the stool and/or tongue may occur", "STOP USE AND ASK DOCTOR IF": "• symptoms get worse • ringing in the ears or loss of hearing occurs • diarrhea lasts more than 2 days", "KEEP OUT OF REACH OF CHILDREN": "In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.", "IF PREGNANT OR BREAST-FEEDING,": "ask a health professional before use.", "ACTIVE INGREDIENT(in each tablet)": "Bismuth subsalicylate 262 mg (total salicylate 102 mg per tablet)", "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 of the blood) • diabetes • gout • arthritis"}