Label: MILK OF MAGNESIA ORIGINAL- magnesium hydroxide liquid

  • 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 May 2, 2012

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  • Active ingredient (in each 15 mL tablespoonful)

    Magnesium hydroxide 1200 mg

  • Purpose

    Saline laxative

  • Uses

    • relieves occasional constipation (irregularity)
    • generally produces bowel movement in 1/2 to 6 hours

  • Warnings

    • kidney disease • a magnesium-restricted diet • stomach pain, nausea, or vomiting • a sudden change in bowel habits that lasts over 14 days taking a prescription drug. This product may interact with certain prescription drugs. • 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 ask a health professional before use.

    Ask a doctor before use if you have




    Ask a doctor or pharmacist before use if you are



    Stop use and ask a doctor if



    If pregnant or breast-feeding,

    In case of overdose, get medical help or contact a Poison Control Center right away. Keep out of reach of children.

  • 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 adults and children 12 years and older: 2 to 4 tablespoonfuls children 6 to 11 years: 1 to 2 tablespoonfuls children under 6 years: ask a doctor









  • Other information

    • magnesium 500 mg • store at room temperature and avoid freezing • close cap tightly after use • each 15 mL tablespoonful contains:


    TAMPER-EVIDENT: Do not use if imprinted neckband is missing or broken.

  • Inactive ingredients

    purified water, sodium hypochlorite

  • MILK OF MAGNESIA ORIGINAL (MAGNESIUM HYDROXIDE) LIQUID

    Label Image
  • INGREDIENTS AND APPEARANCE
    MILK OF MAGNESIA ORIGINAL  
    magnesium hydroxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64725-0649(NDC:57896-649)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM HYDROXIDE1200 mg  in 15 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYPOCHLORITE (UNII: DY38VHM5OD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64725-0649-116 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33401/01/2000
    Labeler - TYA Pharmaceuticals (938389038)
    Registrant - TYA Pharmaceuticals (938389038)
    Establishment
    NameAddressID/FEIBusiness Operations
    TYA Pharmaceuticals938389038RELABEL(64725-0649) , REPACK(64725-0649)