Label: PEPTO KIDS- calcium carbonate tablet, chewable

  • NDC Code(s): 58933-446-24, 58933-446-72
  • Packager: Procter & Gamble Manufactura S de RL de CV
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated August 30, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each tablet)

    Calcium carbonate 400 mg

  • Purpose

    Antacid

  • Uses

    relieves:

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

  • Ask a doctor or pharmacist before use if the child is

    • presently taking a prescription drug. Antacids may interact with certain prescription drugs.
  • Stop use and ask a doctor if

    symptoms last more than two weeks.

  • KEEP OUT OF REACH OF CHILDREN

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

  • Directions

    • 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

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

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

  • Questions?

    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

    Pepto ®

    KIDS

    CALCIUM CARBONATE/ANTACID

    CHEWABLES

    BUBBLE GUM

    FLAVOR

    RELIEVES:

    ACID INDIGESTION

    HEARTBURN
    SOUR STOMACH
    UPSET STOMACH

    24 CHEWABLE TABLETS

    446

  • INGREDIENTS AND APPEARANCE
    PEPTO  KIDS
    calcium carbonate tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58933-446
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB, CARBONATE ION - UNII:7UJQ5OPE7D) CALCIUM CARBONATE400 mg
    Inactive Ingredients
    Ingredient NameStrength
    D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MANNITOL (UNII: 3OWL53L36A)  
    POVIDONE (UNII: FZ989GH94E)  
    SORBITOL (UNII: 506T60A25R)  
    SUCROSE (UNII: C151H8M554)  
    TALC (UNII: 7SEV7J4R1U)  
    Product Characteristics
    ColorpinkScoreno score
    ShapeROUNDSize16mm
    FlavorBUBBLE GUMImprint Code P
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58933-446-241 in 1 CARTON01/21/2018
    124 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC:58933-446-723 in 1 CELLO PACK01/21/2018
    21 in 1 CARTON
    224 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM00107/20/2005
    Labeler - Procter & Gamble Manufactura S de RL de CV (812807550)
    Establishment
    NameAddressID/FEIBusiness Operations
    Hood Container Corporation129850751pack(58933-446)
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