Label: LEADER MILK OF MAGNESIA- magnesium hydroxide suspension

  • 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 February 22, 2022

If you are a consumer or patient please visit this version.

  • Active ingredient (in each 15 mL)

    Magnesium hydroxide 1200 mg

  • Purpose

    Saline laxative

  • Uses

    relieves occasional constipation (irregularity)
    generally produces bowel movement in ½ to 6 hours
  • Warnings

    Ask a doctor before use if you have

    kidney disease
    a magnesium-restricted diet
    stomach pain, nausea, or vomiting
    a sudden change in bowel habits that lasts more than 2 weeks

    Ask a doctor or pharmacist before use if you are

    taking any other drug. Take this product two or more hours before or after other drugs. Laxatives may affect how other drugs work.

    Stop use and ask a doctor if

    you have rectal bleeding or no bowel movement after using this product. These could be signs of a serious condition.
    you need to use a laxative for more than 1 week

    If pregnant or breast-feeding,

    ask a health professional before use.

    Keep out of reach of children.

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

  • Directions

    do not exceed the maximum recommended daily dose in a 24 hour period
    shake well before use
    dose may be taken once a day preferably at bedtime, in divided doses, or as directed by a doctor
    drink a full glass (8 oz) of liquid with each dose
    for accurate dosing, use dose cup provided
    mL = milliliter

    adults and children 12 years and older

    30 mL to 60 mL

    children 6 to 11 years

    15 mL to 30 mL

    children under 6 years

    ask a doctor

  • Other information

    each 15 mL contains: calcium 20 mg and magnesium 595 mg
    does not meet USP requirements for preservative effectiveness
    store at 20º-25ºC (68º-77ºF)
    close cap tightly after use
    avoid freezing
  • Inactive ingredient

    purified water

  • Questions or comments?

    1-800-719-9260

  • Principal Display Panel

    Compare to Phillips’® Milk of Magnesia active ingredient

    GENUINE

    Milk of Magnesia

    Saline Laxative

    Magnesium Hydroxide, 1200 mg per 15 mL

    Comfortable, Cramp Free Relief

    Sugar Free

    Stimulant Free

    Original Flavor

    12 FL OZ (355 mL)

    Leader Milk of Magnesia image
  • INGREDIENTS AND APPEARANCE
    LEADER MILK OF MAGNESIA 
    magnesium hydroxide suspension
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37205-833
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838, HYDROXIDE ION - UNII:9159UV381P) MAGNESIUM HYDROXIDE1200 mg  in 15 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorWHITE (opaque) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37205-833-40355 mL in 1 BOTTLE; Type 0: Not a Combination Product12/01/199205/31/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33412/01/199205/31/2022
    Labeler - Cardinal Health (097537435)