Pepto-bismol

Pepto-bismol
SPL v1
SPL
SPL Set ID 8e84b0e3-a872-5437-e053-2a95a90abd19
Route
ORAL
Published
Effective Date 2019-07-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (262 mg)
Inactive Ingredients
Calcium Carbonate Magnesium Stearate Mannitol Povidone D&c Red No. 27 Aluminum Lake Saccharin Sodium Talc

Identifiers & Packaging

Pill Appearance
Imprint: Pepto;Bismol Shape: round Color: pink Size: 16 mm Score: 1
Marketing Status
OTC MONOGRAPH FINAL Active Since 2019-07-15

Description

Drug Facts

Purpose

Upset stomach reliever and antidiarrheal


Medication Information

Purpose

Upset stomach reliever and antidiarrheal

Description

Drug Facts

Uses

relieves ● travelers' diarrhea ● diarrhea

● upset stomach due to overindulgence in food and drink, including: ● heartburn

● indigestion ● nausea ● gas ● belching ● fullness

Section 42229-5

Drug Facts

Purposes

Upset stomach reliever and antidiarrheal

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 exceed 8 doses (16 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

Questions?

1-800-717-3786

Allergy Alert

Contains salicylate. Do not take if you are

● allergic to salicylates (including aspirin) ● taking other salicylate products

Package Label

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.

Other Information

● each tablet contains: calcium 140 mg, magnesium 9 mg

● salicylate 101 mg ● very low sodium

● avoid excessive heat (over 104°F or 40°C)

Inactive Ingredients

calcium carbonate, D&C Red No. 27 aluminum lake, flavor, magnesium stearate, mannitol, povidone, saccharin sodium, talc

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

Active Ingredient (in Each Tablet)

Bismuth subsalicylate 262 mg

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


Structured Label Content

Uses

relieves ● travelers' diarrhea ● diarrhea

● upset stomach due to overindulgence in food and drink, including: ● heartburn

● indigestion ● nausea ● gas ● belching ● fullness

Section 42229-5 (42229-5)

Drug Facts

Purposes

Upset stomach reliever and antidiarrheal

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 exceed 8 doses (16 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

Questions?

1-800-717-3786

Allergy Alert (Allergy alert)

Contains salicylate. Do not take if you are

● allergic to salicylates (including aspirin) ● taking other salicylate products

Package Label

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.

Other Information (Other information)

● each tablet contains: calcium 140 mg, magnesium 9 mg

● salicylate 101 mg ● very low sodium

● avoid excessive heat (over 104°F or 40°C)

Inactive Ingredients (Inactive ingredients)

calcium carbonate, D&C Red No. 27 aluminum lake, flavor, magnesium stearate, mannitol, povidone, saccharin sodium, talc

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

Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))

Bismuth subsalicylate 262 mg

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 the blood) ● diabetes ● gout ● arthritis


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)