Childrens Pepto by The Procter & Gamble Manufacturing Company Children's Pepto

Childrens Pepto by

Drug Labeling and Warnings

Childrens Pepto by is a Otc medication manufactured, distributed, or labeled by The Procter & Gamble Manufacturing Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

CHILDRENS PEPTO- calcium carbonate tablet, chewable 
The Procter & Gamble Manufacturing Company

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.

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Children's Pepto

Drug Facts

Active ingredient (in each tablet)

Calcium carbonate 400 mg

Purpose

Antacid

Uses

relieves:

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

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

Inactive ingredients

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

Questions?

1-800-944-9606

Dist. by Procter & Gamble,
Cincinnati OH 45202

PRINCIPAL DISPLAY PANEL - 24 Tablet Carton

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
CHILDRENS PEPTO 
calcium carbonate tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 37000-490
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
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MANNITOL (UNII: 3OWL53L36A)  
POVIDONE (UNII: FZ989GH94E)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
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: 37000-490-022 in 1 POUCH; Type 0: Not a Combination Product07/20/200501/20/2020
2NDC: 37000-490-241 in 1 CARTON07/20/200501/20/2020
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 finalpart33107/20/200501/20/2020
Labeler - The Procter & Gamble Manufacturing Company (004238200)

Revised: 3/2018
Document Id: 673c7ff7-0f12-7073-e053-2991aa0ab04a
Set id: 2231d2e1-db04-4efb-9b68-76cd83df67e8
Version: 3
Effective Time: 20180312
 
The Procter & Gamble Manufacturing Company