Label: MILK OF MAGNESIA- magnesium hydroxide suspension

  • NDC Code(s): 69339-153-01, 69339-153-17
  • Packager: Natco Pharma USA LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 1, 2023

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  • Active Ingredient (in each 30 mL cup)

    Magnesium hydroxide 2400 mg

  • Purpose

    Saline laxative

  • Uses

    As a Laxative

    • relieves occasional constipation (irregularity)
    • usually produces bowel movement in ½ to 6 hours
  • WarningsDo not use if you have ever had an allergic reaction to this product or any of its ingredients

    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 (1-800-222-1222).

  • 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, or as directed by a doctor
    • drink a full glass (8 oz) of liquid with each dose
    adults and children 12 years and older 30ml, not more than 60ml in 24 hrs
     children under 12 years of age ask a doctor

  • Other information

    • Each tablespoonful {15ml} contains: magnesium 500mg
    • Sodium Content: not more than 324ppm
    • Store at room temperature, 20-25°C (68-77°F). Avoid freezing.
    • Original flavor
    • sugar free, dye free, alcohol free, gluten free
    • Do not use if lid seal is open or damaged
    • See top of cup for lot number and expiration date
  • Inactive ingredient

    purified water, sodium hypochlorite

  • How SuppliedMilk of Magnesia, USP

    2400mg/30ml is a white to offwhite liquid supplied as follows:
    NDC 69339-153-01
    (1) unit dose cup                    30ml

    NDC 69339-153-17
    40 (4x10) unit dose cups       30ml

    NDC 69339-153-19
    100 (10x10) unit dose cups   30ml

  • Questions or comments?

    201-786-6500

    FOR INSTITUTIONAL USE ONLY

    DASH

    PHARMACEUTICALS

    Distributed by: Dash Pharmaceuticals LLC

    Upper Saddle RIver, NJ 07458

  • Principal Display Panel

    Delivers 30 mL

    NDC 69339-153-01

    Milk of Magnesia, USP

    2,400mg Magnesium Hydroxide/30mL

    Shake Well

    For Institutional Use Only

    3 69339 15301 7

    Lot# 123456

    Exp: MM/YYYY

    DASH Pharmaceuticals LLC

    Upper Saddle River, NJ 07458

    LD153.01.R0721

    DASH-DOSE

    milk of magnesia image

  • INGREDIENTS AND APPEARANCE
    MILK OF MAGNESIA 
    magnesium hydroxide suspension
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69339-153
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM HYDROXIDE2400 mg  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorWHITE (opaque) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69339-153-1740 in 1 BOX, UNIT-DOSE12/27/2021
    1NDC:69339-153-0130 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00712/27/2021
    Labeler - Natco Pharma USA LLC (079590418)
    Establishment
    NameAddressID/FEIBusiness Operations
    GCP Laboratories965480861manufacture(69339-153)
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