791L-Target-Bismuth Subsalicylate 525 mg / 30 mL Oral Suspension

Manufacturer
TARGET CORPORATION | TIME CAP LABORATORIES, INC. | MARKSANS PHARMA LIMITED
Effective date
2025-04-12
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:03:08

Label at a glance#

Product5-Symptom Digestive Relief
Active ingredientBISMUTH SUBSALICYLATE
Label structure17 sections

Label contents#

Full prescribing information#

Drug Facts

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient
(in each 30 mL dose)

Bismuth subsalicylate 525 mg

OTC - PURPOSE SECTION

Purpose

Upset stomach reliever and antidiarrheal

INDICATIONS & USAGE SECTION

Uses relieves

■ travelers’ diarrhea

■ diarrhea

■ upset stomach due to overindulgence in food and drink, including: ■ heartburn ■ indigestion ■ nausea ■ gas ■ belching ■ fullness

WARNINGS SECTION

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

OTC - DO NOT USE SECTION

Do not use if you have
■ an ulcer ■ a bleeding problem ■ bloody or black stool

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have ■ 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

OTC - STOP USE SECTION

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

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 (1-800-222-1222).

DOSAGE & ADMINISTRATION SECTION

Directions
■ shake well before use
■ only use dose cup provided
■ adults and children 12 years and over:

- 30 mL (1 dose) every ½ hour or 60 mL (2 doses) every hour as needed for diarrhea/traveler's diarrhea

- 30 mL (1 dose) every ½ hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea)
■ do not exceed 8 doses (240 mL) 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 SAFETY INFORMATION

Other information
■ each 30 mL dose contains: salicylate 199 mg
■ keep tightly closed ■ protect from freezing
■ avoid excessive heat (over 104°F or 40°C)

INACTIVE INGREDIENT SECTION

Inactive ingredients benzoic acid, D&C red no. 22, D&C red no. 28, flavor, glycerin, purified water, sucralose, xanthan gum

OTC - QUESTIONS SECTION

Questions or comments? Call 1-800-910-6874

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

791L_8OZ791L_8OZ791L_2x16OZ_SLV791L_2x16OZ_SLV791L_2x16OZ_LBL791L_2x16OZ_LBL791L_16OZ791L_16OZ

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308762bismuth subsalicylate 525 MG in 30 mL Oral SuspensionPSN2
308762bismuth subsalicylate 17.5 MG/ML Oral SuspensionSCD2
308762bismuth subsalicylate 1.75 % Oral SuspensionSY2
308762bismuth subsalicylate 262 MG per 15 ML Oral SuspensionSY2
308762bismuth subsalicylate 524 MG per 30 ML Oral SuspensionSY2
308762bismuth subsalicylate 525 MG per 30 ML Oral SuspensionSY2

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
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11673-291-065-Symptom Digestive Relief236 mL in 1 BOTTLE, PLASTICSUSPENSION2362
11673-291-075-Symptom Digestive Relief473 mL in 1 BOTTLE, PLASTICSUSPENSION4732
11673-291-085-Symptom Digestive Relief2 in 1 PACKAGESUSPENSION22

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11673-29111673-291-06, 11673-291-07, 11673-291-08

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

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 CORPORATION28fba615-48ca-8d96-e063-6394a90a27972025-04-12WarningsExact identifier
ndc (package): 11673-291-08
ndc (package): 11673-291-07
ndc (package): 11673-291-06
ndc (product): 11673-291
ndc11 (package): 11673029106
ndc11 (package): 11673029107
ndc11 (package): 11673029108
spl id: 32932e3f-edb6-5d92-e063-6394a90a4c43
spl set id: 28fba615-48ca-8d96-e063-6394a90a2797

Reported adverse events (FAERS/openFDA)#

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