Label: MILK OF MAGNESIA- magnesium hydroxide suspension

  • NDC Code(s): 41250-949-35, 41250-949-40
  • Packager: Meijer Distribution Inc
  • Category: HUMAN OTC DRUG LABEL

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 November 5, 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, potassium 2 mg and sodium 3 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

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

  • Questions or comments?

    1-800-719-9260

  • Principal Display Panel

    Compare to Phillips’® active ingredient

    #1 DOCTOR RECOMMENDED saline laxative active ingredient

    CRAMP FREE

    milk of magnesia

    Magnesium Hydroxide, 1200 mg per 15 mL

    Saline Laxative

    Gentle, Dependable Overnight Relief

    Wild Cherry Flavor

    ALCOHOL 0.4% | Stimulant Free

    26 FL OZ (1 pt 10 OZ) 769 mL

    Milk of Magnesia Label Image 1
    Milk of Magnesia Label Image 2
  • INGREDIENTS AND APPEARANCE
    MILK OF MAGNESIA 
    magnesium hydroxide suspension
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41250-949
    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
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    SUCROSE (UNII: C151H8M554)  
    SORBITOL (UNII: 506T60A25R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    D&C RED NO. 28 (UNII: 767IP0Y5NH)  
    Product Characteristics
    ColorPINK (Opaque Light pink) Score    
    ShapeSize
    FlavorCHERRY (wild cherry) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41250-949-40355 mL in 1 BOTTLE; Type 0: Not a Combination Product11/13/200412/13/2016
    2NDC:41250-949-35769 mL in 1 BOTTLE; Type 0: Not a Combination Product10/18/2004
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33410/18/2004
    Labeler - Meijer Distribution Inc (006959555)
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