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  5. Label Information: Cvs Health Childrens Saline Laxative

FDA Label for Cvs Health Childrens Saline Laxative

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT
    2. PURPOSE
    3. USES
    4. ASK A DOCTOR BEFORE USING ANY LAXATIVE IF CHILD HAS
    5. STOP USE AND CONSULT A DOCTOR IF YOUR CHILD HAS
    6. KEEP OUT OF REACH OF CHILDREN
    7. DIRECTIONS
    8. OTHER INFORMATION
    9. INACTIVE INGREDIENTS
    10. QUESTIONS OR COMMENTS?
    11. PRINCIPAL DISPLAY PANEL

Cvs Health Childrens Saline Laxative Product Label

The following document was submitted to the FDA by the labeler of this product Cvs Pharmacy,inc.. 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



Magnesium hydroxide 400 mg


Purpose



Saline laxative


Uses



  • ▪for relief of occasional constipation
  • ▪this product usually produces bowel movement in 1/2 to 6 hours

Ask A Doctor Before Using Any Laxative If Child Has



  • ▪kidney disease
  • ▪a magnesium-restricted diet
  • ▪abdominal pain, nausea or vomiting
  • ▪a sudden change in bowel habits lasting more than 2 weeks
  • ▪already used a laxative for more than 1 week

Stop Use And Consult A Doctor If Your Child Has



  • ▪has rectal bleeding
  • ▪does not have a bowel movement within 6 hours of taking this product

    • These symptoms may indicate a serious condition.


Keep Out Of Reach Of Children



In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222.


Directions



Use dosage chart for proper dosing. Doses may be taken as a single daily dose or in divided doses. Drink a full glass (8 ounces) of liquid with each dose.

Age

Starting dose

Maximum dose per day

children 6 to under 12 years

3-6 tablets

6 tablets

children 2 to under 6 years 

1-3 tablets 

3 tablets 

children under 2 years

ask a doctor


Other Information



  • •each tablet contains: magnesium 170 mg
  • •store at room temperature

Inactive Ingredients



dextrose, FD&C Red 40 aluminum lake, magnesium stearate, maltodextrin, natural and artificial flavor, sorbitol, starch, sucralose.


Questions Or Comments?



1-866-467-2748


Principal Display Panel



CVS Health™

Compare to the active ingredientPedia-Lax®*

NDC# 69842-912-30

Children’s

Saline Laxative

  • •Digestive relief without cramping
  • •Stimulant-free
  • •Works in ½ to 6 hours

    • For ages 2-11 years

    Watermelon Flavor

    Naturally and Artificially Flavor

    30 CHEWABLE TABLETS

    CVS Health™ Children’s Saline Laxative is a mild and effective laxative designed to be gentle on your little one’s digestive system with no cramping and no stimulants. The chewable tablets make it easy to take.

    IMPORTANT: Keep this carton for future reference on full labeling.

    *This product is not manufactured or distributed by C.B Fleet Company Inc., the distributor of Pedia-Lax®

    Distributed by: CVS Pharmacy, Inc.

    One CVS Drive, Woonsocket, RI 02895

    © 2018 CVS/pharmacy

    CVS.com 1-800-SHOP CVS

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* Please review the disclaimer below.