Stomach Relief

Set ID
37cb2581-3f94-4085-ac77-76b8f77a2486
Manufacturer
Spirit Pharmaceuticals LLC
Effective date
2024-12-10
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:41:54

Key Label Information

Active Ingredients And Purpose

Active Ingredient (in each tablet)

Bismuth subsalicylate 262 mg

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

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

Do not use if you have

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

Ask a doctor before use if you have

• fever • mucus in the stool

Ask a doctor or pharmacist before use if you are if you are

you are taking any drug for • anticoagulation (thinning the blood) • diabetes • gout • arthritis

Directions And Dosage

Directions

• swallow with water, do not chew • adults and children 12 years and over: • 2 softgels (1 dose) every 1/2 hour or 4 softgels (2 doses) every hour as needed for diarrhea • 2 soft gels (1 dose) every 1/2 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 Label Information

Other information

• each softgel contains: Salicylate 99 mg • very low sodium • store between 15–30°C (59–86°F)

Inactive ingredients

Aerosil, beeswax, FD&C Red No. 33, FD&C Yellow No. 6, gelatin, glycerin, light liquid paraffin, purified water, soya lecithin, sodium carboxy methyl cellulose, sorbitol solution, titanium dioxide

Questions or comments?

1-888-333-9792

Pouch

Products

NDC Codes

Ingredients

NameUNIIKind
SYNTHETIC BEESWAX08MNR5YE2RIACT
SILICONZ4152N8IUIIACT
D&C RED NO. 339DBA0SBB0LIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
GELATIN2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
PARAFFINI9O0E3H2ZEIACT
WATER059QF0KO0RIACT
LECITHIN, SOYBEAN1DI56QDM62IACT
HYDROXYMETHYL CELLULOSE273FM27VK1IACT
SORBITOL SOLUTION8KW3E207O2IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
BISMUTH SUBSALICYLATE62TEY51RR1ACTIB

Complete SPL Sections

Drug Facts

SPL UNCLASSIFIED SECTION

Active Ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Bismuth subsalicylate 262 mg

Purpose

OTC - PURPOSE SECTION

Upset stomach reliever and anti-diarrheal

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

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

Do not use if you have

OTC - DO NOT USE SECTION

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

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

• fever • mucus in the stool

Ask a doctor or pharmacist before use if you are if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

you are taking any drug for • anticoagulation (thinning the blood) • diabetes • gout • arthritis

When using this product

OTC - WHEN USING SECTION

• 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,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

• swallow with water, do not chew • adults and children 12 years and over: • 2 softgels (1 dose) every 1/2 hour or 4 softgels (2 doses) every hour as needed for diarrhea • 2 soft gels (1 dose) every 1/2 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

STORAGE AND HANDLING SECTION

• each softgel contains: Salicylate 99 mg • very low sodium • store between 15–30°C (59–86°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aerosil, beeswax, FD&C Red No. 33, FD&C Yellow No. 6, gelatin, glycerin, light liquid paraffin, purified water, soya lecithin, sodium carboxy methyl cellulose, sorbitol solution, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

1-888-333-9792

Pouch

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Source Document

Official SPL XML cached by FDA.report · DailyMed PDF

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Legacy File Index

FolderFileDate
otc28f2733e-963c-f0e0-e063-6394a90a0a9d.xml2024-12-12
otc0befda4d-7104-1da8-e063-6394a90a1600.xml2023-12-08
otceecb8bbf-5944-4814-e053-2a95a90a88ce.xml2022-12-02
otcd16714c9-83a9-456b-e053-2995a90af590.xml2021-11-23
otcStomach Relief.jpg2021-11-23