Label: MILK OF MAGNESIA- magnesium hydroxide liquid 

  • Label RSS
  • 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 04/14

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, magnesium 595 mg, potassium 2 mg and sodium 3 mg
    does not meet USP requirements for preservative effectiveness
    store at 20-25ºC (68-77ºF)
    keep tightly closed
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  • Inactive ingredients

    anhydrous citric acid, D&C red #28, flavor, glycerin, purified water, sorbitol solution, sucrose, xanthan gum

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  • Questions or comments?

    1-800-719-9260

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  • Principal Display Panel

    Compare to the active ingredient in Phillips’® Milk of Magnesia

    MILK OF MAGNESIA

    SALINE LAXATIVE

    MAGNESIUM HYDROXIDE

    Comfortable, cramp free relief

    Gluten free

    Stimulant free

    CHERRY FLAVOR

    ALCOHOL 0.4%

    12 FL OZ (355 mL)

    Milk of Magnesia Image 1
    Milk of Magnesia Image 2
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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:59779-949
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MAGNESIUM HYDROXIDE (MAGNESIUM CATION and HYDROXIDE ION) MAGNESIUM HYDROXIDE 1200 mg  in 15 mL
    Inactive Ingredients
    Ingredient Name Strength
    ANHYDROUS CITRIC ACID  
    GLYCERIN  
    WATER  
    SORBITOL  
    SUCROSE  
    XANTHAN GUM  
    D&C RED NO. 28  
    Product Characteristics
    Color PINK (Opaque Light pink) Score     
    Shape Size
    Flavor CHERRY (wild cherry) Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:59779-949-40 355 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part334 05/05/2005
    Labeler - CVS Pharmacy (062312574)
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