Cvs Health Childrens Tablet, Chewable
FDA Label NDC 69842-912

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Cvs Pharmacy,inc. for the product Cvs Health Childrens (NDC 69842-912). 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, purpose, uses, ask a doctor before using any laxative if child has, stop use and consult a doctor if your child has, keep out of reach of children, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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

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