Childrens Stomach Relief Antacid Liquid
FDA Label NDC 37808-638

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by H E B for the product Childrens Stomach Relief Antacid (NDC 37808-638). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient (in each 5 ml), purpose, use(s), warnings, ask a doctor or pharmacist before use if the child is, stop use and ask doctor if, keep this and all drugs out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient (In Each 5 Ml)

Calcium carbonate 400 mg

Purpose

Antacid

Use(S)

relieves:

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

Warnings

Do  not take more than 15 mL (age 2-5 yrs) or 30 mL (age 6-11 yrs) in a 24-hour period, or use the maximum dosage of this product for more than 2 weeks, except under the advice and supervision of a doctor.

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 Doctor If

symptoms lasts more than two weeks

Keep This And All Drugs Out Of Reach Of Children

.

Directions

  • shake well before use
  • find the right dose on the chart below based on weight (preferred), otherwise use age.
  • repeat dose as needed
  • dosing cup provided
  • mL=milliliter

    • Dosing Chart



    Weight (lbs.) Age  Dose
     under 24 under 2 yrs.ask a doctor 
     24-47 2-5 yrs. 5 mL
     48-95 6-11 yrs. 10 mL


Other Information

  • each 5 mL contains: calcium 161 mg
  • store at controlled room temperature 20-25°C (68°F-77°F)

Inactive Ingredients

benzyl alcohol, D&C yellow#10 dye, FD&C red#40 dye, flavors, glycerin, hydroxyethyl cellulose, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, sorbitol, sucralose, xanthagum.

Questions Or Comments?

1-(609) 860-2600 Mon.- Fri. 8:00 am - 4:30 pm.

Principal Display Panel

Compare to Kid's pepto® active ingredient*
NDC 37808-638-03
H E B
Children's 
Stomach Relief
Calcium Carbonate 400 mg / 5 mL
Antacid
Relief of :


  • Acid Indigestion
  • Heartburn
  • Sour Stomach
  • Upset Stomach

    • Orange Creme Flavor 


    4 FL OZ  (118 mL)

    657-heb.jpg (657 Heb)

    657-heb.jpg (657 Heb)


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