Label: MILK OF MAGNESIA- magnesium hydroxide suspension

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 5, 2022

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each 5 mL)

    Magnesium hydroxide 400 mg

  • Purpose

    Saline laxative

  • Uses

    As an Antacid

    • heartburn
    • upset/sour stomach
    • acid indigestion

    As a Laxative (usually within ½ to 6 hours)

    • occasional constipation (irregularity)
  • 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

    As an Antacid

    • do not exceed the maximum recommended daily dose in a 24 hour period
    • shake well before use
    • can be taken with water
    • mL = milliliter
    adults and children 12 years of age and over5 to 15 mL (1 to 3 teaspoonfuls)
    children under 12 years of ageask a doctor

    As a Laxative

    • do not exceed the maximum recommended daily dose of 60 mL in a 24 hour period
    • shake well before use
    • 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.
    • mL = milliliter; TBSP = Tablespoon
    adults and children 12 years and older30 mL (2 TBSP) to 60 mL (4 TBSP)
    children 6 – 11 years15 mL (1 TBSP) to 30 mL (2 TBSP)
    children under 6 yearsask a doctor
  • Other information

    • each teaspoonful (5 mL) contains: magnesium 400 mg
    • store at room temperature, 20° - 25°C (68° - 77°F). Avoid freezing.
    • Milk of Magnesia USP (white suspension, spearmint flavor) is supplied in the following oral dosage form:
    NDC 0121-0431-30:30 mL unit dose cup. Case contains 100 unit dose cups of 30 mL packaged in 10 trays of 10 unit dose cups each.
  • Inactive ingredients

    flavoring, hydroxypropyl methylcellulose, methylparaben, potassium citrate, propylene glycol, propylparaben, purified water, antifoam af emulsion, sodium saccharin, and sorbitol.

  • Questions or comments?

    Call 1-800-845-8210

  • SPL UNCLASSIFIED SECTION

    MANUFACTURED BY
    Pharmaceutical
    Associates, Inc.

    Greenville, SC 29605

  • PRINCIPAL DISPLAY PANEL - 30 mL Cup Tray Label

    NDC 0121-0431-30

    Milk of Magnesia USP
    ANTACID, SALINE LAXATIVE

    Each 30 mL contains:

    Magnesium Hydroxide
    2400 mg

    SHAKE WELL

    USUAL DOSAGE: See attached Drug Facts

    Package Not Child-Resistant

    Pharmaceutical Associates, Inc.

    Greenville, SC 29605

    F0431300721

    PRINCIPAL DISPLAY PANEL - 30 mL Cup Tray Label
  • INGREDIENTS AND APPEARANCE
    MILK OF MAGNESIA 
    magnesium hydroxide suspension
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0121-0431
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838, HYDROXIDE ION - UNII:9159UV381P) MAGNESIUM HYDROXIDE400 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    HYPROMELLOSE 2910 (4000 MPA.S) (UNII: RN3152OP35)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POTASSIUM CITRATE (UNII: EE90ONI6FF)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    CYCLOMETHICONE 4 (UNII: CZ227117JE)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SORBITOL (UNII: 506T60A25R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorSPEARMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0121-0431-3010 in 1 CASE09/04/1979
    110 in 1 TRAY
    130 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 DrugM00709/04/1979
    Labeler - PAI Holdings, LLC (044940096)
    Establishment
    NameAddressID/FEIBusiness Operations
    PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma097630693manufacture(0121-0431)