FDA.reportPublic FDA data

Ultra Strength digestive relief

Manufacturer
WALGREENS CO.
Effective date
2025-11-26
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:18:16

Label at a glance#

ProductUltra Strength digestive relief
Active ingredientBISMUTH SUBSALICYLATE
Label structure10 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: 1 caplet (1 dose) every ½ hour or 2 caplets (2 doses) every hour as needed for diarrhea 1 caplet (1 dose) every ½ hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea) do not exceed 8 doses (8 caplets) in 24 hours use until diarrhea stops but not more than 2 days children under 12 years : ask a doctor drink plenty of...

Storage and handling

each caplet contains: calcium 54 mg salicylate 199 mg very low sodium store at room temperature

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each caplet)

OTC - ACTIVE INGREDIENT SECTION

Bismuth Subsalicylate 525 mg

Purpose

OTC - PURPOSE SECTION

Upset stomach reliever and anti-diarrheal

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

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

SPL UNCLASSIFIED SECTION

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 ifyou 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 aretaking any drug for

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

OTC - WHEN USING SECTION

When using this producta 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 immediately at 1-800-222-1222.

Directions

DOSAGE & ADMINISTRATION SECTION

  • swallow with water, do not chew
  • adults and children 12 years and over:1 caplet (1 dose) every ½ hour or 2 caplets (2 doses) every hour as needed for diarrhea
  • 1 caplet (1 dose) every ½ hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea)
  • do not exceed 8 doses (8 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

STORAGE AND HANDLING SECTION

  • each caplet contains:calcium 54 mg
  • salicylate 199 mg
  • very low sodium
  • store at room temperature

Inactive ingredients

INACTIVE INGREDIENT SECTION

calcium carbonate, crospovidone, FD&C Red No. 27 Lake, magnesium stearate, microcrystalline cellulose, polysorbate 80, sodium lauryl sulphate.

Questions?

OTC - QUESTIONS SECTION

1-866-467-2748

PRINCIPAL DISPLAY PANEL - 24 Caplet Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to the active Ingredient in Pepto-Bismosol® Ultra Caplets*

NDC 0363-1302-02

Ultra Strength

Digestive Relief

Bismuth Subsalicylate
Upset Stomach Reliever/Antidiarrheal

5 Symptom Digestive Relief

  • Heartburn
  • Indigestion
  • Nausea
  • Upset Stomach
  • Diarrhea

2X CONCENTRATED FORMULA

24 Caplets

Ultra Strength Digestive Relief 24 Caplets
Ultra Strength Digestive Relief 24 Caplets

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1998447bismuth subsalicylate 525 MG Oral TabletPSN4
1998447bismuth subsalicylate 525 MG Oral TabletSCD4

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-1302-02Ultra Strength digestive relief1 in 1 CARTONTABLET14
0363-1302-02Ultra Strength digestive relief24 in 1 BOTTLETABLET244

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0363-13020363-1302-02

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
CALCIUM CARBONATEH0G9379FGKIACT
CROSPOVIDONE (120 .MU.M)68401960MKIACT
D&C RED NO. 272LRS185U6KIACT
MAGNESIUM STEARATE70097M6I30IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
POLYSORBATE 806OZP39ZG8HIACT
SODIUM LAURYL SULFATE368GB5141JIACT
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
Ultra Strength digestive reliefBISMUTH SUBSALICYLATEWALGREENS CO.756e7a47-7e14-4694-84fa-ca6396f7edcc2025-11-26WarningsExact identifier
ndc (package): 0363-1302-02
ndc (product): 0363-1302
ndc11 (package): 00363130202
spl id: 447d20f5-798d-ca2a-e063-6294a90ada0d
spl set id: 756e7a47-7e14-4694-84fa-ca6396f7edcc

Reported adverse events (FAERS/openFDA)#

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