FDA.reportPublic FDA data

First Aid Direct Peptum Tabs

Manufacturer
Cintas Corp | Allegiant Health
Effective date
2025-09-29
Label type
HUMAN OTC DRUG LABEL
Version
13
Source
full-release
Hydrated at
2026-06-01 01:15:11

Label at a glance#

ProductFirst Aid Direct Peptum Tabs
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

chew or dissolve in mouth 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 1/2 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 : ask a doctor drink plenty of fluid...

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Bismuth subsalicylate 262 mg

(each tablet contains 102mg salicylate)

Purpose

OTC - PURPOSE SECTION

Antidiarrheal/Antacid

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 occurs, 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 salicylate (including asprin)
  • taking other salicylate products

OTC - DO NOT USE SECTION

Do not use if you have

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

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

  • ​​fever
  • mucus in stool

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are ​taking any drug for

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

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • ​symptoms get worse
  • 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. ​In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • chew or dissolve in mouth
  • 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 1/2 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: ask a doctor
  • drink plenty of fluids to help prevent dehydration which may accompany diarrhea

Other information

OTHER SAFETY INFORMATION

  • Phenylketonurics: contains phenylalanine 1.1 mg per tablet

Calcium content per tablet: 73mg

  • store at room temperature 15° - 30°C (59° - 86°F)
  • avoid excessive heat (over 40°C or 104°F)
  • do not use if cellophane unit is torn

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions?

OTC - QUESTIONS SECTION

1-800-327-2704  Monday-Friday 8:00am - 5:00pm (CDT)

Principal Display Panel - Box

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Pep Tum​™

Bismuth subsalicylate

COMPARE ACTIVE INGREDIENTS TO PEPTO-BISMOL®*

262 mg

SOOTHING RELIEF FOR:

  • Upset Stomach
  • Diarrhea
  • Heartburn
  • Indigestion
  • Nausea

30 Chewable Tablets

BoxBox

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308761bismuth subsalicylate 262 MG Chewable TabletPSN13
308761bismuth subsalicylate 262 MG Chewable TabletSCD13

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
42961-109-01First Aid Direct Peptum Tabs1 in 1 CELLO PACKTABLET, CHEWABLE113
42961-109-02First Aid Direct Peptum Tabs30 in 1 BOXTABLET, CHEWABLE3013

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
42961-10942961-109-01, 42961-109-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
BISMUTH SUBSALICYLATE62TEY51RR1ACTIB
ACACIA5C5403N26OIACT
ASPARTAMEZ0H242BBR1IACT
CALCIUM CARBONATEH0G9379FGKIACT
D&C RED NO. 27 ALUMINUM LAKEZK64F7XSTXIACT
DEXTRATESG263MI44RUIACT
MAGNESIUM STEARATE70097M6I30IACT
MALTODEXTRIN7CVR7L4A2DIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
PEPPERMINTV95R5KMY2BIACT
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
First Aid Direct Peptum TabsBISMUTH SUBSALICYLATECintas Corpdd14cd57-3f7c-4634-9da9-6f83dc5bae122025-09-29WarningsExact identifier
ndc (package): 42961-109-02
ndc (package): 42961-109-01
ndc (product): 42961-109
ndc11 (package): 42961010901
ndc11 (package): 42961010902
spl id: 504ab819-fdd1-42f0-92af-cf0cc25857a0
spl set id: dd14cd57-3f7c-4634-9da9-6f83dc5bae12

Reported adverse events (FAERS/openFDA)#

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