FDA.reportPublic FDA data

5-Symptom Digestive Relief

Manufacturer
TARGET CORPORATION | TIME CAP LABORATORIES, INC.
Effective date
2024-06-26
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:15:15

Label at a glance#

Product5-Symptom Digestive Relief
Active ingredientBISMUTH SUBSALICYLATE
Label structure9 sections

Indications and uses

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

Dosage and administration

swallow with water, do not chew adults and children 12 years and over: -2 caplets (1 dose) every ½ hour or 4 caplets (2 doses) every hour as needed for diarrhea -2 caplets (1 dose) every ½ hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea) do not exceed 8 doses (16 caplets) in 24 hours use until diarrhea stops but not more than 2 days children under 12 years: ask a doctor drink plent...

Label contents#

Full prescribing information#

Active ingredient (in each caplet)

OTC - ACTIVE INGREDIENT SECTION

Bismuth subsalicylate 262 mg

Purpose

OTC - PURPOSE SECTION

Upset stomach reliever and antidiarrheal

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 taking any drug for

OTC - ASK DOCTOR/PHARMACIST SECTION

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

When using this product

OTC - WHEN USING SECTION

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 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

OVERDOSAGE 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 caplets (1 dose) every ½ hour or 4 caplets (2 doses) every hour as needed for diarrhea
-2 caplets (1 dose) every ½ hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea)

  • do not exceed 8 doses (16 caplets) 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 SAFETY INFORMATION

  • each caplet contains: calcium 27 mg
  • salicylate 99 mg
  • low sodium
  • store at room temperature

Inactive ingredients

INACTIVE INGREDIENT SECTION

calcium carbonate, D&C red #27 aluminum lake, magnesium stearate, mannitol, microcrystalline cellulose, povidone K-30, silicon dioxide, sodium starch glycolate

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-877-290-4008

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

475R-5 syptom Digestive relief-40s-label475R-5 syptom Digestive relief-40s-label475R-5 syptom Digestive relief-40s-IFC475R-5 syptom Digestive relief-40s-IFC

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308760bismuth subsalicylate 262 MG Oral TabletPSN2
308760bismuth subsalicylate 262 MG Oral TabletSCD2

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
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11673-880-445-Symptom Digestive Relief1 in 1 CARTONTABLET12
11673-880-445-Symptom Digestive Relief40 in 1 BOTTLETABLET402

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11673-8805-SYMPTOM DIGESTIVE RELIEF (BISMUTH SUBSALICYLATE) TABLET [TARGET CORPORATION]2Current NDC, 2 package rows20240716_07aa10e2-dd03-f32d-e063-6294a90aad0d.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11673-88011673-880-44

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
POVIDONE K30U725QWY32XIACT
MANNITOL3OWL53L36AIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
D&C RED NO. 27 ALUMINUM LAKEZK64F7XSTXIACT
SODIUM STARCH GLYCOLATE TYPE AH8AV0SQX4DIACT
MAGNESIUM STEARATE70097M6I30IACT
CALCIUM CARBONATEH0G9379FGKIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
BISMUTH SUBSALICYLATE62TEY51RR1ACTIB

Source Document#

Source XML

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
5-Symptom Digestive ReliefBISMUTH SUBSALICYLATETARGET CORPORATION07aa10e2-dd03-f32d-e063-6294a90aad0d2024-06-26WarningsExact identifier
ndc (package): 11673-880-44
ndc (product): 11673-880
ndc11 (package): 11673088044
spl id: 1bc5914c-32b9-d16e-e063-6294a90a5d33
spl set id: 07aa10e2-dd03-f32d-e063-6294a90aad0d

Reported adverse events (FAERS/openFDA)#

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