Stomach Relief

SPL v1

SPL

SPL Set ID 65dbe287-4528-4dbd-9116-6d4812fd4fa2

Route

ORAL

Published

Effective Date 2017-11-28

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Bismuth Cation (262 mg)

Inactive Ingredients

Calcium Carbonate D&c Red No. 27 Dextrose Cherry Magnesium Stearate Maltodextrin Silicon Dioxide Sorbitol

Identifiers & Packaging

Pill Appearance

Imprint: AP;045 Shape: round Color: pink Size: 16 mm Score: 1

Marketing Status

OTC MONOGRAPH FINAL Active Since 2017-11-28

Description

Bismuth subsalicylate 262 mg

Purpose

Upset stomach reliever and antidiarrheal

Medication Information

Purpose

Upset stomach reliever and antidiarrheal

Description

Bismuth subsalicylate 262 mg

Uses

relieves

travelers' diarrhea
diarrhea
upset stomach due to overindulgence in food and drink, including:
- heartburn
- indigestion
- nausea
- gas
- belching
- fullness

Section 50565-1

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

Section 50567-7

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

Section 53414-9

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

Purposes

Upset stomach reliever and antidiarrheal

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 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 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

Drug Facts

Other Information

Each tablet contains: calcium 77 mg, salicylate 102 mg
store at 15°-30°C (59°-86°F)
protect from moisture

Inactive Ingredients

calcium carbonate, D&C red # 27 (Al-lake), dextrose, flavor (cherry), magnesium stearate, maltodextrin, silicon dioxide, sorbitol

Questions Or Comments

Call toll free: 1-855-215-8180

Do Not Use If You Have

an ulcer
a bleeding problem
bloody or black stool

Principal Display Panel

Stomach Relief

30 Tablets 15 Pouches (2 Tablets per Pouch)

NDC: 69842-394-54

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

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 50565-1 (50565-1)

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

Section 50567-7 (50567-7)

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

Section 53414-9 (53414-9)

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

Purposes

Upset stomach reliever and antidiarrheal

Warnings

Reye’s syndrome

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 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

Drug Facts

Other Information

Each tablet contains: calcium 77 mg, salicylate 102 mg
store at 15°-30°C (59°-86°F)
protect from moisture

Inactive Ingredients (Inactive ingredients)

calcium carbonate, D&C red # 27 (Al-lake), dextrose, flavor (cherry), magnesium stearate, maltodextrin, silicon dioxide, sorbitol

Questions Or Comments (Questions or comments)

Call toll free: 1-855-215-8180

Do Not Use If You Have (Do not use if you have)

an ulcer
a bleeding problem
bloody or black stool

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Stomach Relief

30 Tablets 15 Pouches (2 Tablets per Pouch)

NDC: 69842-394-54

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

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 Taking Any Drug For (Ask a doctor or pharmacist before use if you are taking any drug for)

anticoagulation (thinning the blood)
diabetes
gout
arthritis

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Uses": "relieves travelers' diarrhea diarrhea upset stomach due to overindulgence in food and drink, including: heartburn indigestion nausea gas belching fullness", "50565-1": "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.", "50567-7": "When using this product a temporary, but harmless, darkening of the stool and/or tongue may occur", "53414-9": "If pregnant or breast feeding, ask a health professional before use.", "Purposes": "Upset stomach reliever and antidiarrheal", "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 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 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", "Other Information": "Each tablet contains: calcium 77 mg, salicylate 102 mg store at 15°-30°C (59°-86°F) protect from moisture", "Inactive ingredients": "calcium carbonate, D&C red # 27 (Al-lake), dextrose, flavor (cherry), magnesium stearate, maltodextrin, silicon dioxide, sorbitol", "Questions or comments": "Call toll free: 1-855-215-8180", "Do not use if you have": "an ulcer a bleeding problem bloody or black stool", "PRINCIPAL DISPLAY PANEL": "Stomach Relief 30 Tablets 15 Pouches (2 Tablets per Pouch) NDC: 69842-394-54", "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", "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"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:26.715088 · Updated: 2026-03-14T22:54:55.117494