Label: MILK OF MAGNESIA- magnesium hydroxide suspension

  • NDC Code(s): 57237-314-03, 57237-314-31
  • Packager: Rising Pharma Holdings, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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 July 5, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient per 30mL (1 Unit Dose)

    Magnesium hydroxide 2,400 mg

  • Purpose

    Saline laxative

  • Uses

    •   relieves occasional constipation (irregularity)

    •   usually produces bowel movement in ½ hour to 6 hours

  • Warnings

    Ask a doctor before use if you have • Kidney disease • a magnesium-restricted diet • Stomach pain • 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 may 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 accidental 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, in divided doses or as directed by a doctor

    •   drink a full glass (8oz) of liquid with each dose

     agedose
    Adults and children over 12 years of ageTake 30mL (one unit dose) to 60mL (2 unit dose)
    Children under 12 years of ageAsk a doctor

  • Other information

    •   each 30 mL (unit dose) contains​ Magnesium 1000 mg

    •   store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]

    •   protect from freezing

    •   do not use if lid is torn or broken

  • INACTIVE INGREDIENT

    Inactive ingredients purified water, and sodium hypochlorite.

    NDC Information -

    2400 mg/30 mL

    Each 30 mL of Milk of Magnesia contains Magnesium hydroxide 2,400mg and is supplied in the following oral dosage forms:

    NDC 57237-314-03 unit dose cup 30mL
    NDC 57237-314-31 (100x30) unit dose cups 30mL

  • QUESTIONS

    Questions or comments?Call 1-844-474-7464

  • SPL UNCLASSIFIED SECTION

    Distributed by:
    Rising Pharma Holdings, Inc.
    East Brunswick, NJ 08816

    FG-37/Iss.: 04/2023

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    2400 mg/30 mL

    Lid Label NDC 57237-314-03

    Milk-of-Mag-lid-lab-01

    2400 mg/30 mL

    Case Label NDC 57237-314-31

    Milk-of-Mag-case-lab-01

  • INGREDIENTS AND APPEARANCE
    MILK OF MAGNESIA 
    magnesium hydroxide suspension
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57237-314
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838, HYDROXIDE ION - UNII:9159UV381P) MAGNESIUM HYDROXIDE2400 mg  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYPOCHLORITE (UNII: DY38VHM5OD)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57237-314-31100 in 1 BOX, UNIT-DOSE07/05/2023
    1NDC:57237-314-0330 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 finalpart33107/05/2023
    Labeler - Rising Pharma Holdings, Inc. (116880195)
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