Label: CVS HEALTH CHILDRENS SALINE LAXATIVE- magnesium hydroxide tablet, chewable

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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.

Drug Label Information

Updated September 12, 2023

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  • 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
  • Warnings

    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

    V-16415

    CVS® Quality

    Money Back Guarantee

    CVS Health Saline Laxative 30 Chewable Tablets
  • INGREDIENTS AND APPEARANCE
    CVS HEALTH CHILDRENS  SALINE LAXATIVE
    magnesium hydroxide tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-912
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838, HYDROXIDE ION - UNII:9159UV381P) MAGNESIUM HYDROXIDE400 mg
    Inactive Ingredients
    Ingredient NameStrength
    DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    SORBITOL (UNII: 506T60A25R)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    ColorPINKScore2 pieces
    ShapeROUNDSize14mm
    FlavorWATERMELON (naturally and artificially) Imprint Code RP129
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69842-912-301 in 1 CARTON05/16/2019
    130 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33405/16/2019
    Labeler - CVS PHARMACY,INC. (062312574)
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