Childrens Pepto

Manufacturer
The Procter & Gamble Manufacturing Company
Effective date
2018-03-12
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-02 01:01:02

Label at a glance#

ProductChildrens Pepto
Active ingredientCALCIUM CARBONATE
Label structure11 sections

Indications and uses

relieves: heartburn sour stomach acid indigestion upset stomach due to these symptoms or overindulgence in food and drink

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 161 mg sodium free store at room temperature, avoid excessive humidity

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 due to these symptoms or overindulgence in food and drink

Warnings

WARNINGS SECTION

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.

OTC - STOP USE SECTION

Stop use and ask a doctor if 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 161 mg
  • sodium free
  • store at room temperature, avoid excessive humidity

Inactive ingredients

INACTIVE INGREDIENT SECTION

flavor, magnesium stearate, mannitol, povidone, red 27 aluminum lake, sorbitol, sugar, talc

Questions?

OTC - QUESTIONS SECTION

1-800-944-9606

SPL UNCLASSIFIED SECTION

Dist. by Procter & Gamble,
Cincinnati OH 45202

PRINCIPAL DISPLAY PANEL - 24 Tablet Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 37000-490-24

Children's
Pepto

Relieves:

  • Heartburn
  • Acid Indigestion
  • Sour Stomach
  • Upset Stomach
    due to these
    symptoms

CALCIUM
CARBONATE/
ANTACID

BUBBLE GUM FLAVOR

24
CHEWABLE
TABLETS

Principal Display Panel - 24 Tablet Carton
Principal Display Panel - 24 Tablet Carton

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
37000-490-24EA - Each37000-490acc65c79-2af7-40da-9a18-0fcff6b46c4612015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Calcium CarbonateACTIVE INGREDIENTH0G9379FGK1
Carbonate IonACTIVE MOIETY7UJQ5OPE7D1
aluminum oxideINACTIVE INGREDIENTLMI26O69331
D&C RED NO. 27INACTIVE INGREDIENT2LRS185U6K1
magnesium stearateINACTIVE INGREDIENT70097M6I301
mannitolINACTIVE INGREDIENT3OWL53L36A1
povidoneINACTIVE INGREDIENTFZ989GH94E1
sorbitolINACTIVE INGREDIENT506T60A25R1
sucroseINACTIVE INGREDIENTC151H8M5541
talcINACTIVE INGREDIENT7SEV7J4R1U1

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
37000-49037000-490-02, 37000-490-24

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 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 · 267 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
talcTALC7SEV7J4R1UTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL357 mgExact identifier — unii candidate
35 equally ranked IID candidates
povidonePOVIDONEFZ989GH94ETROCHE / ORAL30 mgExact identifier — unii candidate
30 equally ranked IID candidates
talcTALC7SEV7J4R1UOINTMENT / TOPICAL74.6 %w/wExact identifier — unii candidate
35 equally ranked IID candidates
sorbitolSORBITOL506T60A25RINJECTION / INTRASYNOVIAL45 %w/vExact identifier — unii candidate
44 equally ranked IID candidates
mannitolMANNITOL3OWL53L36ASUSPENSION/ DROPS / TOPICAL0.3 %w/vExact identifier — unii candidate
65 equally ranked IID candidates
povidonePOVIDONEFZ989GH94EPOWDER, FOR SUSPENSION / ORAL35 mg/5mlExact identifier — unii candidate
30 equally ranked IID candidates
magnesium stearateMAGNESIUM STEARATE70097M6I30GRANULE / ORAL629 mgExact identifier — unii candidate
39 equally ranked IID candidates
povidonePOVIDONEFZ989GH94ETABLET, DELAYED RELEASE / ORAL53 mgExact identifier — unii candidate
30 equally ranked IID candidates
talcTALC7SEV7J4R1UGRANULE, DELAYED RELEASE / ORAL525 mgExact identifier — unii candidate
35 equally ranked IID candidates
mannitolMANNITOL3OWL53L36AINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS15400 mgExact identifier — unii candidate
65 equally ranked IID candidates
sucroseSUCROSEC151H8M554INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / SUBCUTANEOUS308 mgExact identifier — unii candidate
48 equally ranked IID candidates
mannitolMANNITOL3OWL53L36AINJECTION, SOLUTION / SUBMUCOSAL2.94 %w/vExact identifier — unii candidate
65 equally ranked IID candidates
mannitolMANNITOL3OWL53L36AINJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR300 mgExact identifier — unii candidate
65 equally ranked IID candidates
sorbitolSORBITOL506T60A25RLIQUID / TOPICAL1 %w/wExact identifier — unii candidate
44 equally ranked IID candidates
sorbitolSORBITOL506T60A25RINJECTION / INTRAVENOUS1276 mgExact identifier — unii candidate
44 equally ranked IID candidates
mannitolMANNITOL3OWL53L36ASOLUTION / SUBCUTANEOUS4.54 %w/vExact identifier — unii candidate
65 equally ranked IID candidates
sorbitolSORBITOL506T60A25RLIQUID / ORAL53460 mgExact identifier — unii candidate
44 equally ranked IID candidates
sucroseSUCROSEC151H8M554TROCHE / ORALNAExact identifier — unii candidate
48 equally ranked IID candidates
sucroseSUCROSEC151H8M554POWDER, FOR SOLUTION / ORAL38666 mgExact identifier — unii candidate
48 equally ranked IID candidates
povidonePOVIDONEFZ989GH94ETABLET, FILM COATED, EXTENDED RELEASE / ORAL17 mgExact identifier — unii candidate
30 equally ranked IID candidates
mannitolMANNITOL3OWL53L36AINJECTION, SOLUTION / INTRAVENOUS15400 mgExact identifier — unii candidate
65 equally ranked IID candidates
sucroseSUCROSEC151H8M554INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS2000 mgExact identifier — unii candidate
48 equally ranked IID candidates
magnesium stearateMAGNESIUM STEARATE70097M6I30POWDER / RESPIRATORY (INHALATION)0.13 mgExact identifier — unii candidate
39 equally ranked IID candidates
magnesium stearateMAGNESIUM STEARATE70097M6I30TABLET, SUGAR COATED / ORALNAExact identifier — unii candidate
39 equally ranked IID candidates
mannitolMANNITOL3OWL53L36ASOLUTION/ DROPS / OPHTHALMIC4.6 %w/vExact identifier — unii candidate
65 equally ranked IID candidates
magnesium stearateMAGNESIUM STEARATE70097M6I30POWDER / TOPICAL104 mgExact identifier — unii candidate
39 equally ranked IID candidates
sucroseSUCROSEC151H8M554INJECTION, SUSPENSION, LIPOSOMAL / INTRAVENOUS9.4 %w/vExact identifier — unii candidate
48 equally ranked IID candidates
sorbitolSORBITOL506T60A25RINJECTION / INTRALESIONAL45 %w/vExact identifier — unii candidate
44 equally ranked IID candidates
sorbitolSORBITOL506T60A25RTABLET / ORAL337.28 mgExact identifier — unii candidate
44 equally ranked IID candidates
sucroseSUCROSEC151H8M554GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL18790 mgExact identifier — unii candidate
48 equally ranked IID candidates
sucroseSUCROSEC151H8M554TROCHE / BUCCALNAExact identifier — unii candidate
48 equally ranked IID candidates
povidonePOVIDONEFZ989GH94ESOLUTION / ORAL3000 mgExact identifier — unii candidate
30 equally ranked IID candidates
mannitolMANNITOL3OWL53L36AINJECTION, SUSPENSION / INTRAVENOUS2.5 %w/vExact identifier — unii candidate
65 equally ranked IID candidates
sorbitolSORBITOL506T60A25RCREAM / TOPICAL36.8 %w/wExact identifier — unii candidate
44 equally ranked IID candidates
sorbitolSORBITOL506T60A25RGUM, CHEWING / BUCCAL5110 mgExact identifier — unii candidate
44 equally ranked IID candidates
magnesium stearateMAGNESIUM STEARATE70097M6I30SUSPENSION / ORAL64 mgExact identifier — unii candidate
39 equally ranked IID candidates
magnesium stearateMAGNESIUM STEARATE70097M6I30CAPSULE, EXTENDED RELEASE / ORAL117 mgExact identifier — unii candidate
39 equally ranked IID candidates
mannitolMANNITOL3OWL53L36ASOLUTION / INTRAVENOUS15400 mgExact identifier — unii candidate
65 equally ranked IID candidates
talcTALC7SEV7J4R1UDROPS / ORALNAExact identifier — unii candidate
35 equally ranked IID candidates
sorbitolSORBITOL506T60A25RSYRUP / ORAL4370 mg/5mlExact identifier — unii candidate
44 equally ranked IID candidates
talcTALC7SEV7J4R1UTABLET, SUGAR COATED / ORALNAExact identifier — unii candidate
35 equally ranked IID candidates
aluminum oxideALUMINUM OXIDELMI26O6933SPONGE / TOPICALNAExact identifier — unii candidate
2 equally ranked IID candidates
sorbitolSORBITOL506T60A25REMULSION / TOPICAL7 %w/wExact identifier — unii candidate
44 equally ranked IID candidates
sorbitolSORBITOL506T60A25RSOLUTION, CONCENTRATE / ORAL300 mg/1mlExact identifier — unii candidate
44 equally ranked IID candidates
talcTALC7SEV7J4R1UTABLET, FILM COATED / ORAL91 mgExact identifier — unii candidate
35 equally ranked IID candidates
sucroseSUCROSEC151H8M554CONCENTRATE / ORAL4800 mgExact identifier — unii candidate
48 equally ranked IID candidates
mannitolMANNITOL3OWL53L36AINJECTION, POWDER, FOR SOLUTION / INTRAVENOUS980.4 mgExact identifier — unii candidate
65 equally ranked IID candidates
sorbitolSORBITOL506T60A25RSOLUTION/ DROPS / OPHTHALMIC0.25 %w/vExact identifier — unii candidate
44 equally ranked IID candidates
mannitolMANNITOL3OWL53L36APOWDER / ORAL4352 mgExact identifier — unii candidate
65 equally ranked IID candidates
mannitolMANNITOL3OWL53L36ATABLET / BUCCAL360 mgExact identifier — unii candidate
65 equally ranked IID candidates
mannitolMANNITOL3OWL53L36AINJECTION, POWDER, FOR SUSPENSION / INTRAMUSCULAR164 mgExact identifier — unii candidate
65 equally ranked IID candidates
sucroseSUCROSEC151H8M554SUSPENSION/ DROPS / ORAL3750 mgExact identifier — unii candidate
48 equally ranked IID candidates
magnesium stearateMAGNESIUM STEARATE70097M6I30TABLET, COATED / ORAL184 mgExact identifier — unii candidate
39 equally ranked IID candidates
talcTALC7SEV7J4R1UTABLET, COATED / ORAL320.75 mgExact identifier — unii candidate
35 equally ranked IID candidates
magnesium stearateMAGNESIUM STEARATE70097M6I30IMPLANT / INTRAVITREALNAExact identifier — unii candidate
39 equally ranked IID candidates
sorbitolSORBITOL506T60A25RINJECTION / INTRAMUSCULARNAExact identifier — unii candidate
44 equally ranked IID candidates
sucroseSUCROSEC151H8M554SOLUTION / ORAL70000 mgExact identifier — unii candidate
48 equally ranked IID candidates
magnesium stearateMAGNESIUM STEARATE70097M6I30TABLET, ORALLY DISINTEGRATING / ORAL187 mgExact identifier — unii candidate
39 equally ranked IID candidates
sorbitolSORBITOL506T60A25ROINTMENT / TOPICAL10 %w/wExact identifier — unii candidate
44 equally ranked IID candidates
mannitolMANNITOL3OWL53L36ATABLET, DELAYED RELEASE / ORAL639 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
673c7ff7-0f12-7073-e053-2991aa0ab04a2231d2e1-db04-4efb-9b68-76cd83df67e82018-03-12WarningsExact identifier
spl id: 673c7ff7-0f12-7073-e053-2991aa0ab04a
spl set id: 2231d2e1-db04-4efb-9b68-76cd83df67e8

Reported adverse events (FAERS/openFDA)#

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