FDA.reportPublic FDA data

RITE AID Ultra Strnght

Manufacturer
RITE AID CORPORATION
Effective date
2024-10-30
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:32:12

Label at a glance#

ProductRITE AID Ultra Strnght Pink Bismuth
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

• shake well before use • Only use dose cup provided • adults and children 12 years and over: 15 mL (1 dose) every1/2 hour or 30 mL (2 doses) every hours as needed for diarrhea/traveler’s diarrhea • 15 mL (1dose) every ½ hour as needed for overindulgence (Upset stomach, heartburn, indigestion, nausea) • do not exceed 8 doses (120 mL) in 24 hours • use until diarrhea stops but not more than 2 days • children under ...

Storage and handling

• each 15 mL contains: sodium 10 mg • salicylate 230 mg • low sodium • sugar free • store at room temperature. • protect from freezing • avoid excessive heat (more than 104°F or 40°C).

Label contents#

Full prescribing information#

Active ingredient (in each 15 mL dose)

OTC - ACTIVE INGREDIENT SECTION

Bismuth subsalicylate 525 mg

Purposes

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

OTC - DO NOT USE SECTION

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

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking any drug for

  • 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

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 before use
  • Only use dose cup provided
  • adults and children 12 years and over: 15 mL (1 dose) every1/2 hour or 30 mL (2 doses) every hours as needed for diarrhea/traveler’s diarrhea
  • 15 mL (1dose) every ½ hour as needed for overindulgence (Upset stomach, heartburn, indigestion, nausea)
  • do not exceed 8 doses (120 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 information

STORAGE AND HANDLING SECTION

  • each 15 mL contains: sodium 10 mg
  • salicylate 230 mg
  • low sodium
  • sugar free
  • store at room temperature.
  • protect from freezing
  • avoid excessive heat (more than 104°F or 40°C).

Inactive ingredients

INACTIVE INGREDIENT SECTION

carboxymethylcellulose sodium, D&C Red #22, D&C Red #28, flavor, microcrystalline cellulose, potassium hydroxide, potassium sorbate, purified water, salicylic acid, simethicone emulsion, sodium benzoate, sucralose, xanthan gum

Questions or comments?

OTC - QUESTIONS SECTION

1-866-467-2748

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

*Compare to the active ingredient in Pepto-Bismol® Ultra Strength *

Ultra-Strength

Pink Bismuth

Bismuth Subsalicylate

Upset Stomach Reliever/Antidiarrheal

Original flavor

Relieves:

  • Nausea
  • Heartburn
  • Indigestion
  • Upset Stomach
  • Diarrhea

12FL. OZ. (354 mL)

Distributed By:

*This product is not manufactured or distributed by Procter & Gamble, distributor of Pepto-Bismol® Ultra Strength.

Package Label 354 mL

RITE AID Ultra Stomach Relief 354 mL
RITE AID Ultra Stomach Relief 354 mL

Package Label 236 mL

SPL UNCLASSIFIED SECTION

RITE AID Ultra Strngth Pink Bismuth Subsalicylate 236 mL
RITE AID Ultra Strngth Pink Bismuth Subsalicylate 236 mL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308763bismuth subsalicylate 1050 MG in 30 mL Oral SuspensionPSN3
308763bismuth subsalicylate 35 MG/ML Oral SuspensionSCD3
308763bismuth subsalicylate 1050 MG per 30 ML Oral SuspensionSY3
308763bismuth subsalicylate 525 MG per 15 ML Oral SuspensionSY3

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11822-7070-2RITE AID Ultra StrnghtPink Bismuth354 mL in 1 BOTTLESUSPENSION3543
11822-7070-8RITE AID Ultra StrnghtPink Bismuth236 mL in 1 BOTTLESUSPENSION2363

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11822-7070RITE AID ULTRA STRNGHT PINK BISMUTH (BISMUTH SUBSALICYLATE) SUSPENSION [RITE AID CORPORATION]3Current NDC, 2 package rows20241101_3ffb2bb9-6d6a-4c38-ac59-0ac0d754de28.zip

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11822-707011822-7070-2, 11822-7070-8

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
BISMUTH SUBSALICYLATE62TEY51RR1ACTIB
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDK679OBS311IACT
D&C RED NO. 221678RKX8RTIACT
D&C RED NO. 28767IP0Y5NHIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
POTASSIUM HYDROXIDEWZH3C48M4TIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
WATER059QF0KO0RIACT
SALICYLIC ACIDO414PZ4LPZIACT
DIMETHICONE, UNSPECIFIED92RU3N3Y1OIACT
SODIUM BENZOATEOJ245FE5EUIACT
SUCRALOSE96K6UQ3ZD4IACT
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
RITE AID Ultra Strnght Pink BismuthBISMUTH SUBSALICYLATERITE AID CORPORATION3ffb2bb9-6d6a-4c38-ac59-0ac0d754de282024-10-30WarningsExact identifier
ndc (package): 11822-7070-8
ndc (package): 11822-7070-2
ndc (product): 11822-7070
ndc11 (package): 11822707008
ndc11 (package): 11822707002
spl id: efd117ef-c772-40f4-aa36-e133912fada8
spl set id: 3ffb2bb9-6d6a-4c38-ac59-0ac0d754de28

Reported adverse events (FAERS/openFDA)#

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