Label: 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 October 19, 2018

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  • 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, magnesium 595 mg, and sodium 2 mg
    •
    does not meet USP requirements for preservative effectiveness
    •
    store at 20-25°C (68-77°F)
    •
    close cap tightly after use
    •
    avoid freezing
  • Inactive ingredients

    light mineral oil, peppermint oil, purified water, saccharin sodium

  • Questions or comments?

    1-800-719-9260

  • Principal Display Panel

    Compare to Phillips’® Milk of Magnesia active ingredient

    Milk of Magnesia

    Magnesium Hydroxide 1200 mg per 15 mL

    Saline Laxative

    Comfortable, Cramp Free Relief

    Stimulant Free

    Sugar Free

    Mint Flavor

    12 FL OZ (355 mL)

    milk-of-magnesia-image
  • INGREDIENTS AND APPEARANCE
    MILK OF MAGNESIA 
    magnesium hydroxide suspension
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37808-332
    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
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    Product Characteristics
    ColorWHITE (opaque) Score    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37808-332-40355 mL in 1 BOTTLE; Type 0: Not a Combination Product10/14/1994
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33410/14/1994
    Labeler - H E B (007924756)
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