FDA.reportPublic FDA data

HEB Diarrhea Relief

Manufacturer
HEB
Effective date
2022-07-29
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:50:18

Label at a glance#

ProductHEB Diarrhea Relief Vanilla Flavor
Active ingredientBismuth subsalicylate
Label structure9 sections

Indications and uses

relieves ▪ traveler’s diarrhea ▪ diarrhea ▪ upset stomach due to overindulgence in food and drink ▪ heartburn ▪ indigestion ▪ nausea ▪ gas

Dosage and administration

• shake well immediately before each use • adults and children 12 years of age and older: 30 ml or 2 tablespoonful • for accurate dosing, use convenient pre-measured dose cup • repeat dose every 1/2 hour to 1 hour as needed • do not exceed 8 doses 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...

Storage and handling

• each 15mL tablespoon contains: sodium 10 mg • each 15mL tablespoon contains: salicylate 130 mg • do not use if printed inner seal is broken or missing • store at room temperature

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient (per 15 mL)

OTC - ACTIVE INGREDIENT SECTION

Bismuth Subsalicylate 262 mg

Purposes

OTC - PURPOSE SECTION

Anti-diarrheal/Upset stomach reliever

Uses

INDICATIONS & USAGE SECTION

relieves

  • traveler’s diarrhea
  • diarrhea
  • upset stomach due to overindulgence in food and drink
  • heartburn
  • indigestion
  • nausea
  • gas

Warnings

WARNINGS SECTION

Reye's syndrome:

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

  • 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

  • a sodium-restricted diet
  • fever
  • mucus in the stool

OTC - ASK DOCTOR/PHARMACIST SECTION

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

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

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
  • 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 at 1-800-222-1222.

Directions

DOSAGE & ADMINISTRATION SECTION

  • shake well immediately before each use
  • adults and children 12 years of age and older: 30 ml or 2 tablespoonful
  • for accurate dosing, use convenient pre-measured dose cup
  • repeat dose every 1/2 hour to 1 hour as needed
  • do not exceed 8 doses 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 15mL tablespoon contains: sodium 10 mg
  • each 15mL tablespoon contains: salicylate 130 mg
  • do not use if printed inner seal is broken or missing
  • store at room temperature

Inactive ingredients

INACTIVE INGREDIENT SECTION

caramel, carboxymethylcellulose sodium, microcrystalline cellulose, natural and artificial flavor, potassium sorbate, salicylic acid , simethicone emulsion, sucralose, sucrose, water, xanthan gum

Questions or comments?

OTC - QUESTIONS SECTION

1-866-467-2748

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

H-E-B®

NDC 37808-173-12

Compare to Kaopectate® active ingredient*

Diarrhea Relief

Bismuth Subsalicylate, 262 mg per 15 mL/

Antidiarrheal/Upset Stomach Reliever

Multi-Symptom Relief

Relief of 7 Types of Stomach Ailments

Vanilla Flavor

Contains Salicylates

12 FL OZ (355 mL)

MADE WITH PRIDE & CARE FOR H-E-B® SAN ANTONIA, TX 78204

*This product is not manufactured or distributed by Chattem Inc., the distributor of Kaopectate®.

HEB Diarrhea Relief Bismuth Subsalicylate
HEB Diarrhea Relief Bismuth Subsalicylate

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308762bismuth subsalicylate 525 MG in 30 mL Oral SuspensionPSN4
308762bismuth subsalicylate 17.5 MG/ML Oral SuspensionSCD4
308762bismuth subsalicylate 1.75 % Oral SuspensionSY4
308762bismuth subsalicylate 262 MG per 15 ML Oral SuspensionSY4
308762bismuth subsalicylate 524 MG per 30 ML Oral SuspensionSY4
308762bismuth subsalicylate 525 MG per 30 ML Oral SuspensionSY4

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
37808-173-122024-01-30C16284748780-11030e365-357d-111a-e063-dadaa90a10e2H-E-B ® Diarrheal Relief

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37808-173-12HEB Diarrhea ReliefVanilla Flavor355 mL in 1 BOTTLE, PLASTICSUSPENSION3554

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37808-173HEB DIARRHEA RELIEF VANILLA FLAVOR (BISMUTH SUBSALICYLATE) SUSPENSION [HEB]4Legacy NDC, 1 package rows20220731_b70d4176-8bc1-4863-82df-90ae8391e4a2.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
37808-17337808-173-12

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
Bismuth subsalicylate62TEY51RR1ACTIB
CARAMELT9D99G2B1RIACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDK679OBS311IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
salicylic acidO414PZ4LPZIACT
DIMETHICONE92RU3N3Y1OIACT
SUCRALOSE96K6UQ3ZD4IACT
SUCROSEC151H8M554IACT
WATER059QF0KO0RIACT
XANTHAN GUMTTV12P4NEEIACT

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
a012c7ff-bd0c-4d0f-80e2-b1f5b55dfe30b70d4176-8bc1-4863-82df-90ae8391e4a22022-07-29WarningsExact identifier
spl id: a012c7ff-bd0c-4d0f-80e2-b1f5b55dfe30
spl set id: b70d4176-8bc1-4863-82df-90ae8391e4a2

Reported adverse events (FAERS/openFDA)#

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