Label: MILK OF MAGNESIA CONCENTRATE- magnesium hydroxide suspension

  • NDC Code(s): 0121-0940-00, 0121-0940-10
  • Packager: PAI Holdings, LLC
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated February 3, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each 10 mL)

    Magnesium hydroxide 2400 mg

  • Purpose

    Saline laxative

  • Uses

    As an Antacid

    • heartburn
    • upset/sour stomach
    • acid indigestion

    As a Laxative

    • relieves occasional constipation (irregularity) This product usually produces bowel movement in ½ to 6 hours.
  • Warnings

    Do 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.

  • Directions

    As an Antacid

    • do not exceed the maximum recommended daily dose of 20 mL 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 mL (1 teaspoonful)
    children under 12 years of ageask a doctor

    As a Laxative

    • do not exceed the maximum recommended daily dose 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
    adults and children 12 years and older15 mL to 30 mL
    children under 12 yearsask a doctor
  • Other information

    • each teaspoonful (5 mL) contains: magnesium 1000 mg
    • Sodium Content: 19 mg/10 mL
    • store at room temperature, 20° - 25°C (68° - 77°F). Avoid freezing.
    • Milk of Magnesia Concentrate (white suspension, lemon flavored) is supplied in the following oral dosage form:

    NDC 0121-0940-10: 10 mL unit dose cup, in a tray of ten cups.

  • Inactive ingredients

    glycerin, hydroxypropyl methylcellulose, lemon oil, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate
    dihydrate, sodium saccharin, sorbitol, and sucrose.

  • Questions or comments?

    Call 1-800-845-8210

  • SPL UNCLASSIFIED SECTION

    MANUFACTURED BY

    Pharmaceutical
    Associates, Inc.
    Greenville, SC 29605
    www.paipharma.com

    R07/21

  • PRINCIPAL DISPLAY PANEL - 10 mL Unit-Dose Cup Tray Label

    NDC 0121-0940-10

    Milk of Magnesia Concentrate

    Each 10 mL contains:

    Magnesium Hydroxide 2400 mg.

    ANTACID/ SALINE LAXATIVE

    SHAKE WELL

    Package Not Child-Resistant

    See Insert

    PRINCIPAL DISPLAY PANEL - 10 mL Unit-Dose Cup Tray Label
  • INGREDIENTS AND APPEARANCE
    MILK OF MAGNESIA CONCENTRATE 
    magnesium hydroxide suspension
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0121-0940
    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 10 mL
    Inactive Ingredients
    Ingredient NameStrength
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SORBITOL SOLUTION (UNII: 8KW3E207O2)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SUCROSE (UNII: C151H8M554)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorLEMON (LEMON-0IL) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0121-0940-0010 in 1 CASE01/18/2022
    110 in 1 TRAY
    1NDC:0121-0940-1010 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 DrugM00701/18/2022
    Labeler - PAI Holdings, LLC (044940096)
    Establishment
    NameAddressID/FEIBusiness Operations
    PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma097630693manufacture(0121-0940)
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