FDA.reportPublic FDA data

Upset Stomach Relief to Go

Manufacturer
Breakthrough Products Inc.
Effective date
2014-10-08
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 22:40:33

Label at a glance#

ProductUpset Stomach Relief to Go
Active ingredientBismuth subsalicylate
Label structure11 sections

Indications and uses

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

Dosage and administration

adults and children 12 years and over: see instructions in red box for opening packet place 1 powder on the tongue and swallow with or without water every ½ to 1 hour as needed do not exceed 8 doses in 24 hours use until diarrhea stops but not more than 2 days drink plenty of clear fluids to help prevent dehydration caused by diarrhea children under 12 years: ask a doctor

Storage and handling

each dose contains salicylate 199mg

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (per powder)

OTC - ACTIVE INGREDIENT SECTION

Bismuth subsalicylate 525mg

Purpose

OTC - PURPOSE SECTION

Upset stomach reliever/antidiarrheal

Uses

INDICATIONS & USAGE SECTION

Relieves:

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

Warnings

WARNINGS SECTION

Reye's syndrome

SPL UNCLASSIFIED SECTION

Children and teenagers who have or are recovering from chickenpox 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

SPL UNCLASSIFIED SECTION

Contains salicylate.

OTC - DO NOT USE SECTION

Do not take if you are

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

OTC - DO NOT USE SECTION

Do not use if you have

  • 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

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are taking any drug for:

  • anticoagulation (thinning the blood)
  • diabetes
  • gout
  • arthritis

OTC - WHEN USING SECTION

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

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • symptoms get worse or last more than 2 days
  • ringing in the ears or loss of hearing occurs
  • diarrhea lasts for more than 2 days

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

adults and children 12 years and over:

  • see instructions in red box for opening packet
  • place 1 powder on the tongue and swallow with or without water every ½ to 1 hour as needed
  • do not exceed 8 doses in 24 hours
  • use until diarrhea stops but not more than 2 days
  • drink plenty of clear fluids to help prevent dehydration caused by diarrhea

children under 12 years: ask a doctor

Other information

STORAGE AND HANDLING SECTION

each dose contains salicylate 199mg

Inactive ingredients

INACTIVE INGREDIENT SECTION

citric acid, flavor, glucose, silica, sucralose

Questions?

OTC - QUESTIONS SECTION

1-888-998-7436 (Mon-Fri 9AM-5PM MDT)

SPL UNCLASSIFIED SECTION

Do not use if pouch
is torn or open

distributed by
URGENT Rx®
Breakthrough Products, Inc.
Denver, CO 80202

PRINCIPAL DISPLAY PANEL - 1 Powder Packet

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

New!

NO
WATER
REQUIRED
POUR DIRECTLY IN MOUTH

URGENT Rx®
FAST
POWDERS™

◀ SEE OPENING INSTRUCTIONS ON BACK PANEL ▶

UPSET
STOMACH

URGENT Rx®

RELIEF
TO-GO™

BISMUTH SUBSALICYLATE/
UPSET STOMACH RELIEVER & ANTIDIARRHEAL

cherry

distributed by UrgentRx
1 POWDER PACK

Principal Display Panel - 1 Powder Packet
Principal Display Panel - 1 Powder Packet

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1191695bismuth subsalicylate 525 MG Oral PowderPSN4
1191695bismuth subsalicylate 525 MG Oral PowderSCD4

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
BISMUTH CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0be8e4ae-4d57-49f3-b3a9-e4728b4e8d15Product name120240313
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51596-004-052020-01-31C16284748780-19d75b9d0-bcfe-f424-e053-dadaa90a57ceUpset Stomach Relief to Go ™
51596-004-102020-01-31C16284748780-19d75b9d0-bcfe-f424-e053-dadaa90a57ceUpset Stomach Relief to Go ™
51596-004-122020-01-31C16284748780-19d75b9d0-bcfe-f424-e053-dadaa90a57ceUpset Stomach Relief to Go ™
51596-004-242020-01-31C16284748780-19d75b9d0-bcfe-f424-e053-dadaa90a57ceUpset Stomach Relief to Go ™

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51596-004-01Upset Stomach Relief to Go1 in 1 POUCHPOWDER14
51596-004-05Upset Stomach Relief to Go5 in 1 BOXPOWDER54
51596-004-10Upset Stomach Relief to Go1 in 1 PACKETPOWDER14
51596-004-10Upset Stomach Relief to Go10 in 1 BOXPOWDER104
51596-004-12Upset Stomach Relief to Go12 in 1 BOXPOWDER124
51596-004-24Upset Stomach Relief to Go24 in 1 BOXPOWDER244

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51596-004UPSET STOMACH RELIEF TO GO (BISMUTH SUBSALICYLATE) POWDER [BREAKTHROUGH PRODUCTS INC.]4Legacy NDC, 6 package rows20141017_a019eedf-073d-43c6-ad30-dedb9dd51fbd.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Bismuth subsalicylateACTIVE INGREDIENT62TEY51RR14
BISMUTH CATIONACTIVE MOIETYZS9CD1I8YE4
anhydrous citric acidINACTIVE INGREDIENTXF417D3PSL4
dextroseINACTIVE INGREDIENTIY9XDZ35W24
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU44
sucraloseINACTIVE INGREDIENT96K6UQ3ZD44

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51596-00451596-004-01, 51596-004-05, 51596-004-12, 51596-004-24, 51596-004-10

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
Bismuth subsalicylate62TEY51RR1ACTIB
anhydrous citric acidXF417D3PSLIACT
dextroseIY9XDZ35W2IACT
silicon dioxideETJ7Z6XBU4IACT
sucralose96K6UQ3ZD4IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 3 · 153 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
anhydrous citric acidANHYDROUS CITRIC ACIDXF417D3PSLOIL / TOPICAL2 mgExact identifier — unii candidate
61 equally ranked IID candidates
anhydrous citric acidANHYDROUS CITRIC ACIDXF417D3PSLFILM / BUCCAL9 mgExact identifier — unii candidate
61 equally ranked IID candidates
silicon dioxideSILICON DIOXIDEETJ7Z6XBU4POWDER / ORAL602 mgExact identifier — unii candidate
49 equally ranked IID candidates
dextroseDEXTROSEIY9XDZ35W2TROCHE / ORAL903.5 mgExact identifier — unii candidate
21 equally ranked IID candidates
sucraloseSUCRALOSE96K6UQ3ZD4SYRUP / ORAL80 mgExact identifier — unii candidate
22 equally ranked IID candidates
anhydrous citric acidANHYDROUS CITRIC ACIDXF417D3PSLSOLUTION / OPHTHALMIC0.09 %w/vExact identifier — unii candidate
61 equally ranked IID candidates
sucraloseSUCRALOSE96K6UQ3ZD4POWDER, FOR SOLUTION / ORAL414 mgExact identifier — unii candidate
22 equally ranked IID candidates
silicon dioxideSILICON DIOXIDEETJ7Z6XBU4TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL69 mgExact identifier — unii candidate
49 equally ranked IID candidates
anhydrous citric acidANHYDROUS CITRIC ACIDXF417D3PSLCREAM / TOPICAL1 mgExact identifier — unii candidate
61 equally ranked IID candidates
anhydrous citric acidANHYDROUS CITRIC ACIDXF417D3PSLGEL / TOPICAL3 mgExact identifier — unii candidate
61 equally ranked IID candidates
anhydrous citric acidANHYDROUS CITRIC ACIDXF417D3PSLINJECTION, POWDER, FOR SOLUTION / INTRAVENOUS35 mgExact identifier — unii candidate
61 equally ranked IID candidates
sucraloseSUCRALOSE96K6UQ3ZD4SUSPENSION / ORAL383 mgExact identifier — unii candidate
22 equally ranked IID candidates
anhydrous citric acidANHYDROUS CITRIC ACIDXF417D3PSLINJECTION / PERINEURAL0.02 %w/vExact identifier — unii candidate
61 equally ranked IID candidates
silicon dioxideSILICON DIOXIDEETJ7Z6XBU4TABLET / BUCCAL3 mgExact identifier — unii candidate
49 equally ranked IID candidates
sucraloseSUCRALOSE96K6UQ3ZD4POWDER, FOR SUSPENSION / ORAL400 mgExact identifier — unii candidate
22 equally ranked IID candidates
silicon dioxideSILICON DIOXIDEETJ7Z6XBU4TABLET, ORALLY DISINTEGRATING / ORAL68 mgExact identifier — unii candidate
49 equally ranked IID candidates
anhydrous citric acidANHYDROUS CITRIC ACIDXF417D3PSLSOLUTION, CONCENTRATE / INTRAVENOUS60 mgExact identifier — unii candidate
61 equally ranked IID candidates
silicon dioxideSILICON DIOXIDEETJ7Z6XBU4GRANULE, DELAYED RELEASE / ORAL3.2 mgExact identifier — unii candidate
49 equally ranked IID candidates
silicon dioxideSILICON DIOXIDEETJ7Z6XBU4GEL / DENTAL19 %w/wExact identifier — unii candidate
49 equally ranked IID candidates
anhydrous citric acidANHYDROUS CITRIC ACIDXF417D3PSLTABLET, EXTENDED RELEASE / ORAL312 mgExact identifier — unii candidate
61 equally ranked IID candidates
anhydrous citric acidANHYDROUS CITRIC ACIDXF417D3PSLPOWDER, FOR SUSPENSION / ORAL570 mgExact identifier — unii candidate
61 equally ranked IID candidates
anhydrous citric acidANHYDROUS CITRIC ACIDXF417D3PSLSUSPENSION/ DROPS / OPHTHALMIC0.05 %w/vExact identifier — unii candidate
61 equally ranked IID candidates
silicon dioxideSILICON DIOXIDEETJ7Z6XBU4SUSPENSION, EXTENDED RELEASE / ORAL70 mgExact identifier — unii candidate
49 equally ranked IID candidates
sucraloseSUCRALOSE96K6UQ3ZD4GRANULE, FOR SUSPENSION / ORAL23 mgExact identifier — unii candidate
22 equally ranked IID candidates
silicon dioxideSILICON DIOXIDEETJ7Z6XBU4CAPSULE, EXTENDED RELEASE / ORAL168 mgExact identifier — unii candidate
49 equally ranked IID candidates
anhydrous citric acidANHYDROUS CITRIC ACIDXF417D3PSLINJECTION, SOLUTION, CONCENTRATE / INTRAVENOUS81 mgExact identifier — unii candidate
61 equally ranked IID candidates
anhydrous citric acidANHYDROUS CITRIC ACIDXF417D3PSLINJECTION, SOLUTION / INTRAMUSCULAR25 mgExact identifier — unii candidate
61 equally ranked IID candidates
anhydrous citric acidANHYDROUS CITRIC ACIDXF417D3PSLPOWDER, FOR SOLUTION / ORAL123 mgExact identifier — unii candidate
61 equally ranked IID candidates
anhydrous citric acidANHYDROUS CITRIC ACIDXF417D3PSLTABLET / SUBLINGUAL36 mgExact identifier — unii candidate
61 equally ranked IID candidates
anhydrous citric acidANHYDROUS CITRIC ACIDXF417D3PSLTABLET / BUCCAL30 mgExact identifier — unii candidate
61 equally ranked IID candidates
dextroseDEXTROSEIY9XDZ35W2INJECTION, SOLUTION / INTRATHECAL1925 mgExact identifier — unii candidate
21 equally ranked IID candidates
sucraloseSUCRALOSE96K6UQ3ZD4FILM / ORAL1 mgExact identifier — unii candidate
22 equally ranked IID candidates
anhydrous citric acidANHYDROUS CITRIC ACIDXF417D3PSLAEROSOL, FOAM / TOPICAL6 mgExact identifier — unii candidate
61 equally ranked IID candidates
anhydrous citric acidANHYDROUS CITRIC ACIDXF417D3PSLPASTE / ORAL26 mgExact identifier — unii candidate
61 equally ranked IID candidates
sucraloseSUCRALOSE96K6UQ3ZD4SOLUTION / ORAL800 mgExact identifier — unii candidate
22 equally ranked IID candidates
anhydrous citric acidANHYDROUS CITRIC ACIDXF417D3PSLSUSPENSION, EXTENDED RELEASE / ORAL62 mgExact identifier — unii candidate
61 equally ranked IID candidates
silicon dioxideSILICON DIOXIDEETJ7Z6XBU4GRANULE / ORAL5000 mgExact identifier — unii candidate
49 equally ranked IID candidates
anhydrous citric acidANHYDROUS CITRIC ACIDXF417D3PSLTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL48 mgExact identifier — unii candidate
61 equally ranked IID candidates
sucraloseSUCRALOSE96K6UQ3ZD4LOZENGE / ORAL115 mgExact identifier — unii candidate
22 equally ranked IID candidates
silicon dioxideSILICON DIOXIDEETJ7Z6XBU4TABLET, DELAYED RELEASE PARTICLES / ORAL170 mgExact identifier — unii candidate
49 equally ranked IID candidates
sucraloseSUCRALOSE96K6UQ3ZD4FILM, SOLUBLE / ORAL33 mgExact identifier — unii candidate
22 equally ranked IID candidates
dextroseDEXTROSEIY9XDZ35W2PASTILLE / ORAL826 mgExact identifier — unii candidate
21 equally ranked IID candidates
silicon dioxideSILICON DIOXIDEETJ7Z6XBU4FILM, SOLUBLE / ORAL2 mgExact identifier — unii candidate
49 equally ranked IID candidates
sucraloseSUCRALOSE96K6UQ3ZD4TABLET, CHEWABLE / ORAL28 mgExact identifier — unii candidate
22 equally ranked IID candidates
anhydrous citric acidANHYDROUS CITRIC ACIDXF417D3PSLCONCENTRATE / INTRAVENOUSADJ PHExact identifier — unii candidate
61 equally ranked IID candidates
silicon dioxideSILICON DIOXIDEETJ7Z6XBU4SUPPOSITORY / RECTAL14 mgExact identifier — unii candidate
49 equally ranked IID candidates
silicon dioxideSILICON DIOXIDEETJ7Z6XBU4TABLET, CHEWABLE / ORAL254 mgExact identifier — unii candidate
49 equally ranked IID candidates
silicon dioxideSILICON DIOXIDEETJ7Z6XBU4FILM, EXTENDED RELEASE / TRANSDERMAL49 mgExact identifier — unii candidate
49 equally ranked IID candidates
silicon dioxideSILICON DIOXIDEETJ7Z6XBU4TAMPON / VAGINALNAExact identifier — unii candidate
49 equally ranked IID candidates
dextroseDEXTROSEIY9XDZ35W2INJECTION / INTRASPINAL75 mgExact identifier — unii candidate
21 equally ranked IID candidates
dextroseDEXTROSEIY9XDZ35W2TABLET, COATED / ORAL132 mgExact identifier — unii candidate
21 equally ranked IID candidates
dextroseDEXTROSEIY9XDZ35W2INJECTION / INTRAMUSCULAR5 %w/vExact identifier — unii candidate
21 equally ranked IID candidates
anhydrous citric acidANHYDROUS CITRIC ACIDXF417D3PSLINJECTION / INTRAVENOUS1152 mgExact identifier — unii candidate
61 equally ranked IID candidates
silicon dioxideSILICON DIOXIDEETJ7Z6XBU4TABLET, FILM COATED, EXTENDED RELEASE / ORAL336 mgExact identifier — unii candidate
49 equally ranked IID candidates
silicon dioxideSILICON DIOXIDEETJ7Z6XBU4GEL / NASAL20 mgExact identifier — unii candidate
49 equally ranked IID candidates
anhydrous citric acidANHYDROUS CITRIC ACIDXF417D3PSLLOZENGE / TRANSMUCOSAL44 mgExact identifier — unii candidate
61 equally ranked IID candidates
sucraloseSUCRALOSE96K6UQ3ZD4TABLET / SUBLINGUAL12 mgExact identifier — unii candidate
22 equally ranked IID candidates
silicon dioxideSILICON DIOXIDEETJ7Z6XBU4TABLET, CHEWABLE, EXTENDED RELEASE / ORAL2 mgExact identifier — unii candidate
49 equally ranked IID candidates
silicon dioxideSILICON DIOXIDEETJ7Z6XBU4SUSPENSION / ORAL400 mgExact identifier — unii candidate
49 equally ranked IID candidates
sucraloseSUCRALOSE96K6UQ3ZD4TABLET / ORAL45 mgExact identifier — unii candidate
22 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
b34d453b-5109-4fbe-b4d6-78f8b0dde776a019eedf-073d-43c6-ad30-dedb9dd51fbd2014-10-08WarningsExact identifier
spl id: b34d453b-5109-4fbe-b4d6-78f8b0dde776
spl set id: a019eedf-073d-43c6-ad30-dedb9dd51fbd

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.