Stomach Relief Softgels

Set ID
10143ff8-61f1-4275-89e5-8bd46c662f5a
Manufacturer
Spirit Pharmaceuticals LLC
Effective date
2024-12-11
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:42:12

Key Label Information

Uses

Uses

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

Warnings

Warnings

Directions And Dosage

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 Label Information

Other information

each softgel contains: salicylate 102 mg very low sodium do not exceed 25°C

Inactive ingredients

beeswax, collidal silicon dioxide, FD&C Red#33, FD&C Yellow#6, gelatin, glycerin, light liquid paraffin, povidone, purified water, soya lecithin, sodium carboxymethyl cellulose, sorbitol sorbitan solution, titanium dioxide

Questions or comments?

1-888-333-9792

PRINCIPAL DISPLAY PANEL

Stomach relief Bismuth Subsalicylate 262 mg Upset Stomach Reliever/Antidiarrheal Soothing relief for 5 symptoms: • Heartburn • Indigestion • Upset stomach • Nausea • Diarrhea 12 Softgels

Products

NDC Codes

Ingredients

NameUNIIKind
WATER059QF0KO0RIACT
BISMUTH SUBSALICYLATE62TEY51RR1ACTIB
SILICON DIOXIDEETJ7Z6XBU4IACT
LECITHIN, SOYBEAN1DI56QDM62IACT
YELLOW WAX2ZA36H0S2VIACT
CARBOXYMETHYLCELLULOSE SODIUMK679OBS311IACT
LIGHT MINERAL OILN6K5787QVPIACT
GELATIN2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
D&C RED NO. 339DBA0SBB0LIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
POVIDONEFZ989GH94EIACT
SORBITOL506T60A25RIACT
TITANIUM DIOXIDE15FIX9V2JPIACT

Complete SPL Sections

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

Drug Facts

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

Directions

DOSAGE & ADMINISTRATION SECTION

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

STORAGE AND HANDLING SECTION

each softgel contains: salicylate 102 mg very low sodium do not exceed 25°C

Inactive ingredients

INACTIVE INGREDIENT SECTION

beeswax, collidal silicon dioxide, FD&C Red#33, FD&C Yellow#6, gelatin, glycerin, light liquid paraffin, povidone, purified water, soya lecithin, sodium carboxymethyl cellulose, sorbitol sorbitan solution, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

1-888-333-9792

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Stomach relief Bismuth Subsalicylate 262 mg Upset Stomach Reliever/Antidiarrheal Soothing relief for 5 symptoms: • Heartburn • Indigestion • Upset stomach • Nausea • Diarrhea 12 Softgels

Source Document

Official SPL XML cached by FDA.report · DailyMed PDF

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XML SHA-256
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XML bytes
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Legacy File Index

FolderFileDate
otc2900a39c-7fae-85eb-e063-6294a90af0ed.xml2024-12-13
otc0c04f115-6b0a-417f-e063-6394a90ac489.xml2023-12-09
otc00edd5a9-0a6f-236c-e063-6394a90a4298.xml2023-07-21
otcStomach Relief.jpg2023-07-21