FDA.reportPublic FDA data

PEPT-ACHE

Manufacturer
JHK Inc dba American Safety & First Aid
Effective date
2024-04-24
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:12:48

Label at a glance#

ProductPEPT-ACHE
Active ingredientBISMUTH SUBSALICYLATE
Label structure10 sections

Dosage and administration

do not use more than directed chew or dissolve in mouth use until diarrhea stops but not more than 2 days drink plenty of clear fluids to help prevent dehydration, which may accompany diarrhea do not exceed 16 tablets in 24 hours Adults and children: (12 years and older) Chew 2 tablets every 1/2 to 1 hour or 4 tablets every hour as needed Children under 12 years: ask a doctor

Storage and handling

phenylketonurics: contains phenylalanine 1.1mg per tablet each tablet contains 73mg elemental calcium store at room temperature 59º-86ºF (15º-30ºC) tamper-evident sealed packets do not use if packet is opened or torn

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (In Each Tablet)

OTC - ACTIVE INGREDIENT SECTION

Bismuth subsalicylate 262 mg (each tablet contains 102 mg salicylate)

Purpose

OTC - PURPOSE SECTION

Antidiarrheal/Antacid

Use

INDICATIONS & USAGE SECTION

temporarily relieves:

  • controls diarrhea
  • relieves heartburn, indigestion, nausea and upset stomach without constipating

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 Warning

SPL UNCLASSIFIED SECTION

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

  • bloody or black stool
  • an ulcer
  • a bleeding problem

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • fever
  • mucus in the stool

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are taking a prescription drug for:

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

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • symptoms get worse
  • ringing in the ears or loss of hearing occurs
  • diarrhea lasts more than two days

OTC - WHEN USING SECTION

When using this product: a temporary, but harmless darkening of the stool and/or tongue may occur.

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 accidental overdose, contact a doctor or Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not use more than directed
  • chew or dissolve in mouth
  • use until diarrhea stops but not more than 2 days
  • drink plenty of clear fluids to help prevent dehydration, which may accompany diarrhea
  • do not exceed 16 tablets in 24 hours Adults and children: (12 years and older) Chew 2 tablets every 1/2 to 1 hour or 4 tablets every hour as needed

Children under 12 years: ask a doctor

Other information

STORAGE AND HANDLING SECTION

  • phenylketonurics: contains phenylalanine 1.1mg per tablet
  • each tablet contains 73mg elemental calcium
  • store at room temperature 59º-86ºF (15º-30ºC)
  • tamper-evident sealed packets do not use if packet is opened or torn

Inactive ingredients

INACTIVE INGREDIENT SECTION

acacia gum, aspartame, calcium carbonate, D&C red #27, dextrates, flavoring, magnesium stearate, maltodextrin, microcrystalline cellulose, silicon dioxide

Questions?

OTC - QUESTIONS SECTION

1-866-651-3660 Monday-Friday 8:00am-5:00pm EST

PRINCIPAL DISPLAY PANEL - 36 Tablet Packet Box

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

This product is not manufactured or distributed by Proctor & Gamble
Owner of the registered trademark Pepto-Bismol®.

Pept-Ache

Anti-Diarrheal

  • Temporary relief from upset stomach
  • Soothes nausea, heartburn and
    indigestion
  • Chewable tablets

These quality comfort tablets are formulated and packaged for use in
the workplace and meet ANSI Z308. 1-2015 standards. They are
sealed in tamper-evident packets for safety and convenience.

36 Tablets • 1 Tablet Per Packet

PRINCIPAL DISPLAY PANEL - 36 Tablet Packet Box
PRINCIPAL DISPLAY PANEL - 36 Tablet Packet Box

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308761bismuth subsalicylate 262 MG Chewable TabletPSN2
308761bismuth subsalicylate 262 MG Chewable TabletSCD2

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73598-1232-12024-05-20C16284748780-11030e365-639f-111a-e063-dadaa90a10e2PEPT-ACHE
73598-1232-12024-01-30C16284748780-11030e365-639f-111a-e063-dadaa90a10e2PEPT-ACHE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73598-1232-1PEPT-ACHE1 in 1 PACKETTABLET, CHEWABLE12
73598-1232-1PEPT-ACHE36 in 1 BOXTABLET, CHEWABLE362

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73598-1232PEPT-ACHE (BISMUTH SUBSALICYLATE) TABLET, CHEWABLE [JHK INC DBA AMERICAN SAFETY & FIRST AID]2Current NDC, Legacy NDC, 2 package rows20240522_894c1912-cd24-4ddf-b7e7-dae9dd64b280.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73598-123273598-1232-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
BISMUTH SUBSALICYLATE62TEY51RR1ACTIB
ACACIA5C5403N26OIACT
ASPARTAMEZ0H242BBR1IACT
CALCIUM CARBONATEH0G9379FGKIACT
D&C RED NO. 272LRS185U6KIACT
DEXTRATESG263MI44RUIACT
MAGNESIUM STEARATE70097M6I30IACT
MALTODEXTRIN7CVR7L4A2DIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
SILICON DIOXIDEETJ7Z6XBU4IACT

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
PEPT-ACHEBISMUTH SUBSALICYLATEJHK Inc dba American Safety & First Aid894c1912-cd24-4ddf-b7e7-dae9dd64b2802024-04-24WarningsExact identifier
ndc (package): 73598-1232-1
ndc (product): 73598-1232
ndc11 (package): 73598123201
spl id: d994e7c7-adc5-4ab7-a89a-318ea09b2bb1
spl set id: 894c1912-cd24-4ddf-b7e7-dae9dd64b280

Reported adverse events (FAERS/openFDA)#

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