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  5. Label Information: Childrens Stomach Relief Antacid

FDA Label for Childrens Stomach Relief Antacid

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT (IN EACH 5 ML)
    2. PURPOSE
    3. USE(S)
    4. WARNINGS
    5. ASK A DOCTOR OR PHARMACIST BEFORE USE IF THE CHILD IS
    6. STOP USE AND ASK DOCTOR IF
    7. KEEP THIS AND ALL DRUGS OUT OF REACH OF CHILDREN
    8. DIRECTIONS
    9. OTHER INFORMATION
    10. INACTIVE INGREDIENTS
    11. QUESTIONS OR COMMENTS?
    12. PRINCIPAL DISPLAY PANEL

Childrens Stomach Relief Antacid Product Label

The following document was submitted to the FDA by the labeler of this product H E B. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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



* Please review the disclaimer below.