Label: MILK OF MAGNESIA- magnesium hydroxide liquid

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

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 10/12

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

  • Active ingredient (in each 15 mL TBSP)

    Magnesium hydroxide 1200 mg

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  • Purpose

    Saline laxative

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  • Uses

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

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  • Directions

    shake well before use
    do not exceed the maximum recommended daily dose in a 24 hour period
    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
    TBSP = tablespoonful

    adults and children 12 years and older

    2 to 4 TBSP.

    children 6 to 11 years

    1 to 2 TBSP.

    children under 6 years

    ask a doctor

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  • Other information

    each tablespoon (15 mL) contains: calcium 20 mg and magnesium 595 mg
    does not meet USP requirements for preservative effectiveness
    store at 20º-25ºC (68º-77ºF)
    keep tightly closed
    avoid freezing
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  • Inactive ingredients

    purified water

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  • Questions or comments?

    1-800-719-9260

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  • Principal Display Panel

    Compare to Phillips'® Milk of Magnesia Original active ingredient

    MILK OF MAGNESIA

    Magnesium Hydroxide

    Saline Laxative

    Comfortable, Cramp Free Relief

    Stimulant Free

    Sugar Free

    Original Flavor

    GLUTEN FREE

    Milk of Magnesia Front Label
    Milk of Magnesia Back Label
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  • INGREDIENTS AND APPEARANCE
    MILK OF MAGNESIA 
    magnesium hydroxide liquid
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:37808-396
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MAGNESIUM HYDROXIDE (MAGNESIUM CATION) MAGNESIUM HYDROXIDE 1200 mg  in 15 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    Product Characteristics
    Color WHITE (opaque) Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:37808-396-40 355 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part334 06/09/1992
    Labeler - H E B (007924756)
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