FDA.reportPublic FDA data

Rite Aid Stomach Relief Bismuth Subsalicylate 262 mg 30 Chewable Tablets

Manufacturer
RITE AID CORPORATION
Effective date
2024-10-30
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 00:32:22

Label at a glance#

ProductRite Aid Stomach Relief
Active ingredientBISMUTH SUBSALICYLATE
Label structure8 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

• chew completely or dissolve tablets in mouth. Do not swallow tablets whole. • adults and children 12 years and over: • 2 tablets (1 dose) every ½ hour or 4 tablets (2 doses) every hour as needed for diarrhea • 2 tablets (1 dose) every ½ hour as needed for over indulgence (upset stomach, heartburn, indigestion, nausea. • do not exceed 8 doses (16 tablets) in 24 hours • use until diarrhea stops but not more than 2...

Storage and handling

• each tablet contains: salicylate 102 mg • store at room temperature. • avoid excessive heat TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF STRIP UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

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 of 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, ask a health professional before use.

OTC - PREGNANCY OR BREAST FEEDING SECTION

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 immediately at 1-800-222-1222

Directions

DOSAGE & ADMINISTRATION SECTION

  • chew completely or dissolve tablets in mouth. Do not swallow tablets whole.
  • adults and children 12 years and over:
  • 2 tablets (1 dose) every ½ hour or 4 tablets (2 doses) every hour as needed for diarrhea
  • 2 tablets (1 dose) every ½ hour as needed for over indulgence (upset stomach, heartburn, indigestion, nausea.
  • do not exceed 8 doses (16 tablets) in 24 hours
  • use until diarrhea stops but not more than 2 days
  • children under 12 years: ask a doctor
  • drink plenty clear fluids to help prevent dehydration caused by diarrhea.

Other information

STORAGE AND HANDLING SECTION

  • each tablet contains: salicylate 102 mg
  • store at room temperature.
  • avoid excessive heat

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF STRIP UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.

Inactive ingredients

INACTIVE INGREDIENT SECTION

D&C Red No. 27 lake, flavor, magnesium stearate, maltodextrin, microcrystalline cellulose, sorbitol, sucralose.

Questions or comments?

OTC - QUESTIONS SECTION

1-866-467-2748

Principal Display

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC# 11822-4320-0

Compare to the active ingredient in Pepto-Bismol® Chewables*

STOMACH RELIEF

CHEWABLE

BISMUTH SUBSALICYLATE 262 mg

UPSET STOMACH RELIEVER / ANTIDIARRHEAL

5 SYMPTOMS DIGESTIVE RELIEF:

  • Heartburn
  • Indigestion
  • Nausea
  • Upset Stomach
  • Diarrhea

CHERRY FLAVOR

NATURALLY AND ARTIFICIALLY FLAVORED

30 CHEWABLE TABLETS

DISTRIBUTED BY:

RITE AID, 30 HUNTER LANE,

CAMP HILL, PA 17011

www.riteaid.com

SATISFACTION GUARANTEE

IF you’re not satisfied, we’ll happily refund your money.

IMPORTANT: Keep this carton for future reference on full labeling.

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

RITE AID STOAMCH RELIEF CHEWABLE TABLETS
RITE AID STOAMCH RELIEF CHEWABLE TABLETS

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308761bismuth subsalicylate 262 MG Chewable TabletPSN6
308761bismuth subsalicylate 262 MG Chewable TabletSCD6

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
11822-4320-0Rite Aid Stomach Relief5 in 1 CARTONTABLET, CHEWABLE56
11822-4320-0Rite Aid Stomach Relief6 in 1 BLISTER PACKTABLET, CHEWABLE66

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11822-4320RITE AID STOMACH RELIEF (BISMUTH SUBSALICYLATE) TABLET, CHEWABLE [RITE AID CORPORATION]6Current NDC, Legacy NDC, 2 package rows20241101_e3d49cf7-922f-438f-bc62-487a9e4db025.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11822-432011822-4320-0

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
BISMUTH SUBSALICYLATE62TEY51RR1ACTIB
D&C RED NO. 272LRS185U6KIACT
MAGNESIUM STEARATE70097M6I30IACT
MALTODEXTRIN7CVR7L4A2DIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
SORBITOL506T60A25RIACT
SUCRALOSE96K6UQ3ZD4IACT

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 Stomach ReliefBISMUTH SUBSALICYLATERITE AID CORPORATIONe3d49cf7-922f-438f-bc62-487a9e4db0252024-10-30WarningsExact identifier
ndc (package): 11822-4320-0
ndc (product): 11822-4320
ndc11 (package): 11822432000
spl id: 9471b558-23c1-4b29-8e48-6dc0c9020288
spl set id: e3d49cf7-922f-438f-bc62-487a9e4db025

Reported adverse events (FAERS/openFDA)#

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