Pepto Bismol® Cherry Chewable tablets

Manufacturer
The Procter & Gamble Manufacturing Company
Effective date
2023-10-18
Label type
HUMAN OTC DRUG LABEL
Version
14
Source
legacy-cache
Hydrated at
2026-08-01 21:23:55

Label at a glance#

ProductPepto-Bismol
Active ingredientBISMUTH SUBSALICYLATE
Label structure20 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 or dissolve in mouth adults and children 12 years and over: 2 tablets (1 dose) every 1/2 hour or 4 tablets (2 doses) every hour as needed for diarrhea 2 tablets (1 dose) every ½ hour as needed for overindulgence (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 of c...

Storage and handling

each tablet contains: calcium 140 mg, magnesium 9 mg salicylate 99 mg low sodium avoid excessive heat (over 104°F or 40°C)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Bismuth subsalicylate 262 mg

Active ingredient (in each tablet) 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

OTC - DO NOT USE SECTION

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

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 right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • chew or dissolve in mouth
  • adults and children 12 years and over: 2 tablets (1 dose) every 1/2 hour or 4 tablets (2 doses) every hour as needed for diarrhea
  • 2 tablets (1 dose) every ½ hour as needed for overindulgence (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 of clear fluids to help prevent dehydration caused by diarrhea

Other information

STORAGE AND HANDLING SECTION

  • each tablet contains:calcium 140 mg, magnesium 9 mg
  • salicylate 99 mg
  • low sodium
  • avoid excessive heat (over 104°F or 40°C)

Inactive ingredients

INACTIVE INGREDIENT SECTION

adipic acid, calcium carbonate, D&C Red No. 27 aluminum lake, FD&C Red No. 40 aluminum lake, flavor, magnesium stearate, mannitol, povidone, saccharin sodium, talc

Questions?

OTC - QUESTIONS SECTION

1-800-717-3786

SPL UNCLASSIFIED SECTION

TAMPER EVIDENT: Do not use if the printed inner wrap is broken or missing.

SPL UNCLASSIFIED SECTION

MADE IN MEXICO

DIST. BY PROCTER & GAMBLE

CINCINNATI OH 45202

PRINCIPAL DISPLAY PANEL - 30 Tablet Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Pepto
Bismol ®

Bismuth Subsalicylate
Upset Stomach Reliever/ Antidiarrheal

CHEWABLES

CHERRY

5 SYMPTOM

RELIEF

NAUSEA
HEARTBURN
INDIGESTION
UPSET STOMACH
DIARRHEA

30 CHEWABLE TABLETS

018018

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
37000-018-04EA - Each37000-01830354768-a57d-41a9-a694-683cc6a21c0212015-10-02
37000-018-06EA - Each37000-018e255c08c-8628-44b6-acca-bfa6e5b6900e12015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Bismuth subsalicylateACTIVE INGREDIENT62TEY51RR11
bismuth subsalicylateACTIVE MOIETY62TEY51RR11
aluminum oxideINACTIVE INGREDIENTLMI26O69331
calcium carbonateINACTIVE INGREDIENTH0G9379FGK1
D&C red no. 27INACTIVE INGREDIENT2LRS185U6K1
FD&C red no. 40INACTIVE INGREDIENTWZB9127XOA1
magnesium stearateINACTIVE INGREDIENT70097M6I301
mannitolINACTIVE INGREDIENT3OWL53L36A1
povidoneINACTIVE INGREDIENTFZ989GH94E1
saccharin sodium dihydrateINACTIVE INGREDIENTSB8ZUX40TY1
talcINACTIVE INGREDIENT7SEV7J4R1U1

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
37000-01837000-018-02, 37000-018-04, 37000-018-12

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 5 · 252 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
magnesium stearateMAGNESIUM STEARATE70097M6I30INSERT / VAGINAL69 mgExact identifier — unii candidate
39 equally ranked IID candidates
calcium carbonateCALCIUM CARBONATEH0G9379FGKGUM, CHEWING / BUCCAL3492 mgExact identifier — unii candidate
15 equally ranked IID candidates
saccharin sodium dihydrateSACCHARIN SODIUMSB8ZUX40TYELIXIR / ORAL15 mg/5mlExact identifier — unii candidate
34 equally ranked IID candidates
saccharin sodium dihydrateSACCHARIN SODIUMSB8ZUX40TYSUSPENSION / ORAL5000 mg/5mlExact identifier — unii candidate
34 equally ranked IID candidates
mannitolMANNITOL3OWL53L36AINJECTION, POWDER, FOR SUSPENSION / INTRAMUSCULAR164 mgExact identifier — unii candidate
65 equally ranked IID candidates
povidonePOVIDONEFZ989GH94ECAPSULE, EXTENDED RELEASE / ORAL56 mgExact identifier — unii candidate
30 equally ranked IID candidates
saccharin sodium dihydrateSACCHARIN SODIUMSB8ZUX40TYSUSPENSION / RECTAL290 mgExact identifier — unii candidate
34 equally ranked IID candidates
calcium carbonateCALCIUM CARBONATEH0G9379FGKCAPSULE / ORAL349.9 mgExact identifier — unii candidate
15 equally ranked IID candidates
magnesium stearateMAGNESIUM STEARATE70097M6I30GRANULE, FOR SUSPENSION / ORAL14 mgExact identifier — unii candidate
39 equally ranked IID candidates
mannitolMANNITOL3OWL53L36ASUSPENSION/ DROPS / OPHTHALMIC3.3 %w/vExact identifier — unii candidate
65 equally ranked IID candidates
mannitolMANNITOL3OWL53L36ACAPSULE, EXTENDED RELEASE / ORAL160 mgExact identifier — unii candidate
65 equally ranked IID candidates
talcTALC7SEV7J4R1UTABLET, DELAYED RELEASE PARTICLES / ORAL56 mgExact identifier — unii candidate
35 equally ranked IID candidates
saccharin sodium dihydrateSACCHARIN SODIUMSB8ZUX40TYSOLUTION / DENTAL0.05 %w/vExact identifier — unii candidate
34 equally ranked IID candidates
FD&C red no. 40FD&C RED NO. 40WZB9127XOAPOWDER, FOR SOLUTION / ORAL0.33 mg/5mlExact identifier — unii candidate
28 equally ranked IID candidates
calcium carbonateCALCIUM CARBONATEH0G9379FGKTABLET, CHEWABLE / ORAL1650 mgExact identifier — unii candidate
15 equally ranked IID candidates
mannitolMANNITOL3OWL53L36ASOLUTION/ DROPS / OPHTHALMIC4.6 %w/vExact identifier — unii candidate
65 equally ranked IID candidates
magnesium stearateMAGNESIUM STEARATE70097M6I30TABLET / SUBLINGUAL17.5 mgExact identifier — unii candidate
39 equally ranked IID candidates
mannitolMANNITOL3OWL53L36ATABLET, FILM COATED, EXTENDED RELEASE / ORAL543 mgExact identifier — unii candidate
65 equally ranked IID candidates
magnesium stearateMAGNESIUM STEARATE70097M6I30POWDER / ORAL25 mgExact identifier — unii candidate
39 equally ranked IID candidates
mannitolMANNITOL3OWL53L36ATABLET, CHEWABLE / ORAL3726 mgExact identifier — unii candidate
65 equally ranked IID candidates
povidonePOVIDONEFZ989GH94ETABLET, ORALLY DISINTEGRATING / ORAL15.03 mgExact identifier — unii candidate
30 equally ranked IID candidates
saccharin sodium dihydrateSACCHARIN SODIUMSB8ZUX40TYTABLET, CHEWABLE / ORAL84 mgExact identifier — unii candidate
34 equally ranked IID candidates
talcTALC7SEV7J4R1UTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL357 mgExact identifier — unii candidate
35 equally ranked IID candidates
calcium carbonateCALCIUM CARBONATEH0G9379FGKTABLET, DELAYED RELEASE / ORAL8.4 mgExact identifier — unii candidate
15 equally ranked IID candidates
mannitolMANNITOL3OWL53L36ATROCHE / ORAL14594 mgExact identifier — unii candidate
65 equally ranked IID candidates
magnesium stearateMAGNESIUM STEARATE70097M6I30DROPS / ORALNAExact identifier — unii candidate
39 equally ranked IID candidates
saccharin sodium dihydrateSACCHARIN SODIUMSB8ZUX40TYWAFER / ORAL8 mgExact identifier — unii candidate
34 equally ranked IID candidates
FD&C red no. 40FD&C RED NO. 40WZB9127XOACAPSULE, COATED / ORALNAExact identifier — unii candidate
28 equally ranked IID candidates
saccharin sodium dihydrateSACCHARIN SODIUMSB8ZUX40TYSYRUP / ORAL24 mgExact identifier — unii candidate
34 equally ranked IID candidates
magnesium stearateMAGNESIUM STEARATE70097M6I30LOZENGE / TRANSMUCOSAL100 mgExact identifier — unii candidate
39 equally ranked IID candidates
FD&C red no. 40FD&C RED NO. 40WZB9127XOAELIXIR / ORAL12.5 mg/5mlExact identifier — unii candidate
28 equally ranked IID candidates
calcium carbonateCALCIUM CARBONATEH0G9379FGKCAPSULE, DELAYED RELEASE / ORAL20 mgExact identifier — unii candidate
15 equally ranked IID candidates
saccharin sodium dihydrateSACCHARIN SODIUMSB8ZUX40TYTABLET, ORALLY DISINTEGRATING / ORAL10 mgExact identifier — unii candidate
34 equally ranked IID candidates
mannitolMANNITOL3OWL53L36ACAPSULE / ORAL1562 mgExact identifier — unii candidate
65 equally ranked IID candidates
mannitolMANNITOL3OWL53L36ATABLET, COATED / ORAL177.7 mgExact identifier — unii candidate
65 equally ranked IID candidates
mannitolMANNITOL3OWL53L36AINJECTION, SUSPENSION / INTRAMUSCULAR71 mgExact identifier — unii candidate
65 equally ranked IID candidates
mannitolMANNITOL3OWL53L36ACAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
65 equally ranked IID candidates
saccharin sodium dihydrateSACCHARIN SODIUMSB8ZUX40TYPASTE / DENTAL0.3 %w/wExact identifier — unii candidate
34 equally ranked IID candidates
saccharin sodium dihydrateSACCHARIN SODIUMSB8ZUX40TYSOLUTION / RECTAL665 mgExact identifier — unii candidate
34 equally ranked IID candidates
magnesium stearateMAGNESIUM STEARATE70097M6I30WAFER / ORAL66 mgExact identifier — unii candidate
39 equally ranked IID candidates
talcTALC7SEV7J4R1UPELLET / ORAL69 mgExact identifier — unii candidate
35 equally ranked IID candidates
talcTALC7SEV7J4R1UTABLET, FILM COATED, EXTENDED RELEASE / ORAL60 mgExact identifier — unii candidate
35 equally ranked IID candidates
FD&C red no. 40FD&C RED NO. 40WZB9127XOACAPSULE, DELAYED RELEASE / ORAL2 mgExact identifier — unii candidate
28 equally ranked IID candidates
povidonePOVIDONEFZ989GH94ESUSPENSION / AURICULAR (OTIC)NAExact identifier — unii candidate
30 equally ranked IID candidates
mannitolMANNITOL3OWL53L36ALOZENGE / ORAL20546 mgExact identifier — unii candidate
65 equally ranked IID candidates
povidonePOVIDONEFZ989GH94ETABLET / ORAL216 mgExact identifier — unii candidate
30 equally ranked IID candidates
saccharin sodium dihydrateSACCHARIN SODIUMSB8ZUX40TYOINTMENT / TOPICALNAExact identifier — unii candidate
34 equally ranked IID candidates
magnesium stearateMAGNESIUM STEARATE70097M6I30TROCHE / ORAL315 mgExact identifier — unii candidate
39 equally ranked IID candidates
talcTALC7SEV7J4R1USUSPENSION, EXTENDED RELEASE / ORAL46 mgExact identifier — unii candidate
35 equally ranked IID candidates
FD&C red no. 40FD&C RED NO. 40WZB9127XOADROPS / ORALNAExact identifier — unii candidate
28 equally ranked IID candidates
mannitolMANNITOL3OWL53L36ASUSPENSION, EXTENDED RELEASE / ORAL2464.6 mgExact identifier — unii candidate
65 equally ranked IID candidates
talcTALC7SEV7J4R1UCAPSULE, DELAYED RELEASE / ORAL420 mgExact identifier — unii candidate
35 equally ranked IID candidates
povidonePOVIDONEFZ989GH94ECAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
30 equally ranked IID candidates
D&C red no. 27D&C RED NO. 272LRS185U6KTABLET, EXTENDED RELEASE / ORAL1.43 mgExact identifier — unii candidate
4 equally ranked IID candidates
magnesium stearateMAGNESIUM STEARATE70097M6I30CAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
39 equally ranked IID candidates
FD&C red no. 40FD&C RED NO. 40WZB9127XOACONCENTRATE / ORAL0.04 mg/1mlExact identifier — unii candidate
28 equally ranked IID candidates
mannitolMANNITOL3OWL53L36ATABLET, DELAYED RELEASE / ORAL639 mgExact identifier — unii candidate
65 equally ranked IID candidates
povidonePOVIDONEFZ989GH94ESOLUTION / OPHTHALMIC1.8 %w/vExact identifier — unii candidate
30 equally ranked IID candidates
mannitolMANNITOL3OWL53L36AGRANULE / ORAL1328 mgExact identifier — unii candidate
65 equally ranked IID candidates
mannitolMANNITOL3OWL53L36AWAFER / ORAL642 mgExact identifier — unii candidate
65 equally ranked IID candidates

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
0b6642f7-b536-9db2-e063-6294a90ac3424b199888-59fe-4ac9-b199-8f9fd593bd302023-11-30WarningsExact identifier
spl set id: 4b199888-59fe-4ac9-b199-8f9fd593bd30

Reported adverse events (FAERS/openFDA)#

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