Stomach Relief

Stomach Relief
SPL v2
SPL
SPL Set ID 9ae1bcd1-30c3-40f3-87e6-633c19d72cb2
Route
ORAL
Published
Effective Date 2025-11-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Bismuth (262 mg)
Inactive Ingredients
Fd&c Red No. 3 Fd&c Yellow No. 6 Gelatin Glycerin Lecithin, Soybean Polyethylene Glycol 400 Polysorbate 20 Polysorbate 80 Povidone Sorbitol Water Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: SD0 Shape: capsule Color: pink Size: 14 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-11-11

Description

Drug Facts

Purpose

Upset stomach reliever and anti-diarrheal


Medication Information

Purpose

Upset stomach reliever and anti-diarrheal

Description

Drug Facts

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults & for children even if you do not notice any signs or symptoms.

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 ar e taking any drug for

• 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

Do not use if you have

• an ulcer

• a bleeding problem

• bloody or black stool

Section 53414-9

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

uses

relieves:

• travelers' diarrhea

• diarrhea

• upset stomach due to

• overindulgence in food and drink, including:

• heartburn

• indigestion

• nausea

• gas

• belching

• fullness

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

• swallow with water, do not chew

• adults and children 12 years and over:

• 2 softgels every ½ hour or 4 softgels every hour as needed for diarrhea

• 2 softgels every ½ hour to 1 hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea)

• do not exceed 8 doses (16 softgels) 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 softgel contains: salicylate 99 mg

• very low sodium

• store between 20-25° C (68-77° F)

Inactive Ingredients

FD&C red #33, FD&C yellow #6, gelatin, glycerin, lecithin, polyethylene glycol-400, polysorbate 20, polysorbate 80, povidone, sorbitan, sorbitol solution*, purified water, titanium dioxide *may contain these ingredients

Questions Or Comments?

1-800-373-6981 (toll-free)

Principal Display Panel

ValuRx

Compare to the active ingredient in Pepto-Bismol® LiquicapsTM†

Stomach Relief

Bismuth Subsalicylate

Upset Stomach Reliever/Antidiarrheal

Soothing Relieves of 5 Symptoms:

• Nausea

• Heartburn

• Indigestion

• Upset Stomach

• Diarrhea

Carton

Active Ingredient (in Each Softgel)

Bismuth subsalicylate 262 mg


Structured Label Content

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults & for children even if you do not notice any signs or symptoms.

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 ar e taking any drug for

• 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)

Do not use if you have

• an ulcer

• a bleeding problem

• bloody or black stool

Section 53414-9 (53414-9)

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

Purpose

Upset stomach reliever and anti-diarrheal

uses (Uses)

relieves:

• travelers' diarrhea

• diarrhea

• upset stomach due to

• overindulgence in food and drink, including:

• heartburn

• indigestion

• nausea

• gas

• belching

• fullness

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

• swallow with water, do not chew

• adults and children 12 years and over:

• 2 softgels every ½ hour or 4 softgels every hour as needed for diarrhea

• 2 softgels every ½ hour to 1 hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea)

• do not exceed 8 doses (16 softgels) 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 (Other information)

• each softgel contains: salicylate 99 mg

• very low sodium

• store between 20-25° C (68-77° F)

Inactive Ingredients (Inactive ingredients)

FD&C red #33, FD&C yellow #6, gelatin, glycerin, lecithin, polyethylene glycol-400, polysorbate 20, polysorbate 80, povidone, sorbitan, sorbitol solution*, purified water, titanium dioxide *may contain these ingredients

Questions Or Comments? (Questions or comments?)

1-800-373-6981 (toll-free)

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

ValuRx

Compare to the active ingredient in Pepto-Bismol® LiquicapsTM†

Stomach Relief

Bismuth Subsalicylate

Upset Stomach Reliever/Antidiarrheal

Soothing Relieves of 5 Symptoms:

• Nausea

• Heartburn

• Indigestion

• Upset Stomach

• Diarrhea

Carton

Active Ingredient (in Each Softgel) (Active ingredient (in each softgel))

Bismuth subsalicylate 262 mg


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)