Label: MILK OF MAGNESIA- magnesium hydroxide suspension

  • NDC Code(s): 63739-196-01, 63739-196-10
  • Packager: McKesson Corporation dba SKY Packaging
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated February 7, 2024

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

View All Sections
  • Active ingredient(s)

    Magnesium hydroxide 400mL

  • Purpose

    Saline laxative

  • Use(s)

         As an antacid

    • heartburn
    • upset/sour stomach
    • acid indigestion

    As a Laxative (usually within 1/2 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

    Pregnancy/Breastfeeding 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

    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 63739-196-10:30 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

    Call 1-800-845-8210

  • PRINCIPAL DISPLAY PANEL

    MANUFACTURED BY
    Pharmaceutical
    Associates, Inc.
    Greenville, SC 29605

    PRINCIPAL DISPLAY PANEL - 30 mL Cup Tray Label

    NDC 63739-196-10

    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

    DISTRIBUTED BY

    SKY Packaging

    Memphis, TN 38141

    NDC 63739-196-01

    F0431C300923

  • INGREDIENTS AND APPEARANCE
    MILK OF MAGNESIA 
    magnesium hydroxide suspension
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63739-196
    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:63739-196-1010 in 1 CASE01/29/2024
    110 in 1 TRAY
    1NDC:63739-196-0110 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 DrugM00701/29/2024
    Labeler - McKesson Corporation dba SKY Packaging (140529962)
    Registrant - PAI Holdings, LLC dba Pharmaceutical Associates, Inc. (044940096)
    Establishment
    NameAddressID/FEIBusiness Operations
    PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma044940096analysis(63739-196) , label(63739-196) , manufacture(63739-196) , pack(63739-196)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!