Label: MILK OF MAGNESIA- magnesium hydroxide suspension

  • 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 January 24, 2012

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  • Active Ingredients

    Magnesium hydroxide 1200 mg

  • Purpose

    Saline laxative

  • Uses

    • relieves occasional constipation (irregularity)
    • usually produces bowel movement in 1/2 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 over 14 days

  • Ask a doctor or pharmacist before use if you are

    taking any other drug.  Take this product 2 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 this and all drugs out of the reach of children

    In case of accidental overdose, get medical help or contact a Poison Control Center right away.

  • 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, in divided doses, or as directed by a doctor
    • drink a full glass (8oz) of liquid with each dose
    adults and children 12 years and older
    		2 to 4 tabletspoonfuls (TBSP)
    children 6 to 11 years
    		1 to 2 tablespoonfuls (TBSP)
    children under 6 years
    		ask a doctor


  • Other information

    • each 15 mL tablespoonful contains:  magnesium 500 mg
    • store at room temperature and avoid freezing
    • close cap tightly after use
    • TAMPER-EVIDENT:  Do not use if imprinted neckband is missing or broken.


  • Inactive Ingredients

    flavor, purified water, saccharin sodium, sodium hypochlorite

  • Principal Display Panel

    Compare to
    Active Ingredient in
    Phillips Milk of Magnesia

    Rugby Milk of Magnesia is distributed by
    Rugby Laboratories, Inc.
    Duluth, GA   30097


    Additional barcode labeling by;
    Physicians Total Care, Inc.
    Tulsa, Oklahoma    74146



    Milk of Magnesia
    Magnesium Hydroxide 1200mg
    Saline Laxative
    Mint Flavor

    Net Contents
    16 fl oz (473 mL)
    image of package label

  • INGREDIENTS AND APPEARANCE
    MILK OF MAGNESIA 
    magnesium hydroxide suspension
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54868-2345(NDC:0536-2470)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM HYDROXIDE - UNII:NBZ3QY004S) MAGNESIUM HYDROXIDE1200 mg  in 15 mL
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    SODIUM HYPOCHLORITE (UNII: DY38VHM5OD)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorMINT (mint) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54868-2345-0473 mL in 1 BOTTLE, PLASTIC
    2NDC:54868-2345-2355 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33406/19/1997
    Labeler - Physicians Total Care, Inc. (194123980)
    Establishment
    NameAddressID/FEIBusiness Operations
    Physicians Total Care, Inc.194123980relabel
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