Label: CHILDRENS ORAL SALINE LAXATIVE- magnesium hydroxide tablet, chewable

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 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
    ▪
    constipation continues after 1 week of use, contact your child's doctor
    ▪
    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 & artificial flavor, sorbitol, starch, sucralose.

  • Questions or comments?

    1-866-467-2748

  • PRINCIPAL DISPLAY PANEL

    *Compare to the active ingredient in Pedia-Lax®

    NDC# 49035-307-30

    Children’s Oral Saline Laxative

    •
    Treats constipation
    •
    Relief in ½ to 6 hours
    •
    Safe and gentle for kids

    For ages 2-11 years

    Watermelon Flavor

    Naturally and Artificially Flavored

    30 Chewable Tablets

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

    Poop Should Just Happen.

    These tablets are designed for quick, yet gentle relief in 30 minutes to 6 hours. Tasty watermelon-flavored chewable tablets are appropriately dosed for children and allow relief without the painful cramping sometimes associated with stimulant laxatives.

    Distributed by:

    Wal-Mart Stores, Inc., Bentonville, AR 72716

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

    Childrens Oral Saline Laxative 30 Chewable Tablets
  • INGREDIENTS AND APPEARANCE
    CHILDRENS ORAL SALINE LAXATIVE 
    magnesium hydroxide tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49035-307
    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)  
    WATERMELON (UNII: 231473QB6R)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    SORBITOL (UNII: 506T60A25R)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    ColorPINK (light) Score2 pieces
    ShapeROUNDSize14mm
    FlavorWATERMELONImprint Code RP129
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49035-307-301 in 1 CARTON03/10/2020
    130 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00703/10/2020
    Labeler - WAL-MART STORES,INC., (051957769)
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