FDA.reportPublic FDA data

Pepto ®  Kids Chewable Tablets

Manufacturer
The Procter & Gamble Manufacturing Company | Hood Container Corporation
Effective date
2023-10-06
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
legacy-cache
Hydrated at
2026-08-01 21:24:53

Label at a glance#

ProductPepto Kids
Active ingredientCALCIUM CARBONATE
Label structure14 sections

Indications and uses

relieves: heartburn sour stomach acid indigestion upset stomach associated with these symptoms

Dosage and administration

find the right dose on chart below based on weight (preferred), otherwise use age repeat dose as needed do not take more than 3 tablets (ages 2-5) or 6 tablets (ages 6-11) in a 24-hour period, or use the maximum dosage for more than two weeks, except under the advice and supervision of a doctor. Dosing Chart Weight (lbs.) Age Dose under 24 under 2 yrs ask a doctor 24-47 2-5 yrs 1 tablet 48-95 6-11 yrs 2 tablets

Storage and handling

each tablet contains: calcium 160 mg sodium free Do not exceed 25°C. Preserve in well-closed containers.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Calcium carbonate 400 mg

Purpose

OTC - PURPOSE SECTION

Antacid

Uses

INDICATIONS & USAGE SECTION

relieves:

  • heartburn
  • sour stomach
  • acid indigestion
  • upset stomach associated with these symptoms

Ask a doctor or pharmacist before use if the child is

OTC - ASK DOCTOR/PHARMACIST SECTION

  • presently taking a prescription drug. Antacids may interact with certain prescription drugs.

Stop use and ask a doctor if

OTC - STOP USE SECTION

symptoms last more than two weeks.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep this and all drugs out of the reach of children.

Directions

DOSAGE & ADMINISTRATION SECTION

  • find the right dose on chart below based on weight (preferred), otherwise use age
  • repeat dose as needed
  • do not take more than 3 tablets (ages 2-5) or 6 tablets (ages 6-11) in a 24-hour period, or use the maximum dosage for more than two weeks, except under the advice and supervision of a doctor.

Dosing Chart

Weight (lbs.)AgeDose
under 24under 2 yrsask a doctor
24-472-5 yrs1 tablet
48-956-11 yrs2 tablets

Other information

STORAGE AND HANDLING SECTION

  • each tablet contains: calcium 160 mg
  • sodium free
  • Do not exceed 25°C. Preserve in well-closed containers.

Inactive ingredients

INACTIVE INGREDIENT SECTION

D&C Red No. 27 aluminum lake, flavor, magnesium stearate, mannitol, povidone, sorbitol, sugar, talc

Questions?

OTC - QUESTIONS SECTION

1-800-944-9606

SPL UNCLASSIFIED SECTION

TAMPER EVIDENT: Do not use if inner printed seal on bottle is broken or missing.

SPL UNCLASSIFIED SECTION

MADE IN MEXICO
DIST. BY PROCTER & GAMBLE,
CINCINNATI, OH 45202

PRINCIPAL DISPLAY PANEL - 24 Tablet Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Pepto ®

KIDS

Calcium Carbonate/Antacid

CHEWABLES

BUBBLE GUM

FLAVOR

RELIEVES:

ACID INDIGESTION
HEARTBURN
SOUR STOMACH
UPSET STOMACH

24 CHEWABLE TABLETS

446446

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
37000-446-242021-02-12C16284748780-1ba0f9c33-3792-a910-e053-dadaa90a0b85Pepto ®  Kids Chewable Tablets
37000-446-242021-01-29C16284748780-1ba0f9c33-3792-a910-e053-dadaa90a0b85Pepto ®  Kids Chewable Tablets

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
37000-44637000-446-24, 37000-446-72

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
D&C RED NO. 27 ALUMINUM LAKEZK64F7XSTXIACT
MAGNESIUM STEARATE70097M6I30IACT
MANNITOL3OWL53L36AIACT
POVIDONEFZ989GH94EIACT
SORBITOL506T60A25RIACT
SUCROSEC151H8M554IACT
TALC7SEV7J4R1UIACT
CALCIUM CARBONATEH0G9379FGKACTIB

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
0b79667f-5008-63a9-e063-6294a90ac117673b54ec-a6af-4236-e053-2a91aa0aec862023-12-01WarningsExact identifier
spl set id: 673b54ec-a6af-4236-e053-2a91aa0aec86

Reported adverse events (FAERS/openFDA)#

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