Label: MILK OF MAGNESIA- magnesium hydroxide suspension

  • NDC Code(s): 0121-0527-10
  • Packager: Pharmaceutical Associates, 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 May 9, 2018

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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 0121-0527-10: 10 mL unit dose cup. Case contains 100 unit dose cups of 10 mL packaged in 10 trays of 10 unit dose cups each.

  • Inactive ingredients

    antifoam af emulsion, flavoring, glycerin, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, sodium saccharin, sodium salts of polymerized alkylnaphthalenesulfonic acid, 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

    R03/18

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

    NDC 0121-0527-10

    Milk of Magnesia Concentrate

    ANTACID/ SALINE LAXATIVE

    Each 10 mL contains:

    Magnesium Hydroxide
    2400 mg

    SHAKE WELL

    USUAL DOSAGE: See attached Drug Facts

    This unit-dose package is not child-resistant.

    Store at 20° - 25°C (68° - 77°F)
    [See USP Controlled Room Temperature].

    Protect from freezing.

    10 x 10 mL Unit-Dose Cups

    Pharmaceutical
    Associates, Inc.
    Greenville, SC 29605

    T0527100318
    R03/18

    PRINCIPAL DISPLAY PANEL - 10 mL Unit-Dose Cup Tray Label
  • INGREDIENTS AND APPEARANCE
    MILK OF MAGNESIA 
    magnesium hydroxide suspension
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0121-0527
    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
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SORBITOL (UNII: 506T60A25R)  
    SUCROSE (UNII: C151H8M554)  
    FORMALDEHYDE/SODIUM NAPHTHALENESULFONATE COPOLYMER (3000 MW) (UNII: 90D834OZUI)  
    CYCLOMETHICONE 4 (UNII: CZ227117JE)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorLEMONImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0121-0527-1010 in 1 CASE04/20/1982
    110 in 1 TRAY
    110 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 finalpart33104/20/1982
    Labeler - Pharmaceutical Associates, Inc. (044940096)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharmaceutical Associates, Inc.097630693manufacture(0121-0527)
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