Label: MILK OF MAGNESIA ORIGINAL- magnesium hydroxide liquid

  • NDC Code(s): 57896-649-12, 57896-649-16, 57896-649-28
  • Packager: Geri-Care Pharmaceuticals, Corp
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated November 8, 2023

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  • Active ingredient (in each 15 mL tablespoonful)

    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 a prescription drug.
    This product may interact with certain prescription drugs.

    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.

  • 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 older2 to 4 tablespoonfuls
    children 6 to 11 years1 to 2 tablespoonfuls
    children under 6 yearsask a doctor

  • Other information

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

    purified water, sodium hypochlorite

  • Questions or comments?

    1-800-540-3765

  • package Label

    1

  • INGREDIENTS AND APPEARANCE
    MILK OF MAGNESIA ORIGINAL 
    magnesium hydroxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57896-649
    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
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYPOCHLORITE (UNII: DY38VHM5OD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57896-649-12355 mL in 1 BOTTLE; Type 0: Not a Combination Product07/01/2011
    2NDC:57896-649-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product07/01/2011
    3NDC:57896-649-283785 mL in 1 BOTTLE; Type 0: Not a Combination Product04/01/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00701/01/2000
    Labeler - Geri-Care Pharmaceuticals, Corp (611196254)
    Registrant - GCP Laboratories (965480861)
    Establishment
    NameAddressID/FEIBusiness Operations
    GCP Laboratories965480861manufacture(57896-649) , pack(57896-649)
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