FDA.reportPublic FDA data

Rite Aid Digestive Relief

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 00:32:16

Label at a glance#

ProductRite Aid Digestive 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

▪ swallow with water, do not chew ▪ adults and children 12 years and older: 2 caplets every 1/2 to 1 hour as needed ▪ do not exceed 8 doses (16 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

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each caplet)

Bismuth subsalicylate 262 mg

OTC - PURPOSE SECTION

Purpose

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 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

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

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.

OVERDOSAGE SECTION

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 older: 2 caplets every 1/2 to 1 hour as needed
  • do not exceed 8 doses (16 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

OTHER SAFETY INFORMATION

  • each caplet contains: calcium 27 mg, sodium 3 mg
  • salicylate 99 mg
  • low sodium
  • sugar free
  • store at room temperature.

Questions or comments?

OTC - QUESTIONS SECTION

1-866-467-2748

Inactive Ingredients

INACTIVE INGREDIENT SECTION

calcium carbonate, crospovidone, D&C Red No. 27, magnesium stearate, maltodextrin, microcrystalline cellulose, sodium lauryl sulfate.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC# 11822-1254-0

Compare to the active ingredient Pepto-Bismol®*

DIGESTIVE RELIEF

BISMUTH SUBSALICYLATE 262 mg

UPSET STOMACH RELIEVER/ ANTIDIARRHEAL

5 SYMPTOMS RELIEF

  • Heartburn
  • Indigestion
  • Nausea
  • Upset Stomach
  • Diarrhea

40 CAPLETS

TAMPER EVIDENT: DO NOT USE IF PRINTED INNER SEAL UNDER CAP IS BROKEN OR MISSING

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.

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

Rite Aid Digestive Relief Bismuth Subsalicylate 262 mg
Rite Aid Digestive Relief Bismuth Subsalicylate 262 mg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308760bismuth subsalicylate 262 MG Oral TabletPSN6
308760bismuth subsalicylate 262 MG Oral 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
11822-1254-0Rite Aid Digestive Relief40 in 1 BOTTLETABLET, FILM COATED406
11822-1254-0Rite Aid Digestive Relief1 in 1 CARTONTABLET, FILM COATED16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11822-1254RITE AID DIGESTIVE RELIEF (BISMUTH SUBSALICYLATE) TABLET, FILM COATED [RITE AID CORPORATION]6Current NDC, Legacy NDC, 2 package rows20241101_816c4ec4-46d1-4e8e-ad91-a11946c48769.zip

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
11822-125411822-1254-0

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
BISMUTH SUBSALICYLATE62TEY51RR1ACTIB
CALCIUM CARBONATEH0G9379FGKIACT
CROSPOVIDONE (120 .MU.M)68401960MKIACT
D&C RED NO. 272LRS185U6KIACT
MAGNESIUM STEARATE70097M6I30IACT
MALTODEXTRIN7CVR7L4A2DIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
SODIUM LAURYL SULFATE368GB5141JIACT

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 Digestive ReliefBISMUTH SUBSALICYLATERITE AID CORPORATION816c4ec4-46d1-4e8e-ad91-a11946c487692024-10-30WarningsExact identifier
ndc (package): 11822-1254-0
ndc (product): 11822-1254
ndc11 (package): 11822125400
spl id: 71b12479-5c18-49f3-8c4c-5b5afbd333d8
spl set id: 816c4ec4-46d1-4e8e-ad91-a11946c48769

Reported adverse events (FAERS/openFDA)#

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