Label: MILK OF MAGNESIA- magnesium hydroxide suspension

  • Category: HUMAN OTC DRUG LABEL

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 August 12, 2013

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

View All Sections
  • ACTIVE INGREDIENT

    Active ingredient (in each 15 mL tablespoonful)
    Magnesium hydroxide 1200 mg

  • PURPOSE

    Purpose
    Saline laxative

  • INDICATIONS & USAGE

    Uses

    • relieves occasional constipation (irregularity)
    • generally produces bowel movement in 1/2 to 6 hours
  • WARNINGS

    Warnings

  • ASK DOCTOR

    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 DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if you are taking a prescription drug.
    This product may interact with certain prescription drugs.

  • STOP USE

    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 OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. In case of overdose, get medical help or contact a
    Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    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 (8 oz) of liquid with each dose


    adults and children 12 years and older: 2 to 4 tablespoonfuls (TBSP)
    children 6 to 11 years: 1 to 2 tablespoonfuls (TBSP)
    children under 6 years: ask a doctor

  • OTHER SAFETY INFORMATION

    Other information

    • each 15 mL tablespoonful contains: magnesium 500 mg
    • store at room temperature and avoid freezing
    • close cap tightly after use
  • INACTIVE INGREDIENT

    Inactive ingredients
    purified water, sodium hypochlorite

  • PRINCIPAL DISPLAY PANEL



    ———PRINCIPAL DISPLAY PANEL———NDC: 24451-788-30
    MILK OF MAGNESIA
    DELIVERS 30 mL
    CONTAINING:
    MAGNESIUM HYDROXIDE
    2400 mg
    SALINE LAXATIVE
    ORIGINAL FLAVOR
    SUGAR FREE
    SHAKE WELL
    Exp: 00/00/00   Lot # 00000

    Rpk By: Safecor Health LLC
    Woburn, MA 01801
    Dist. By: LLC Federal Solutions
    Miami, FL 33132

    product label

  • INGREDIENTS AND APPEARANCE
    MILK OF MAGNESIA 
    magnesium hydroxide suspension
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24451-788(NDC:0904-0788)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM HYDROXIDE2400 mg  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYPOCHLORITE (UNII: DY38VHM5OD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24451-788-30100 in 1 BOX
    130 mL in 1 CUP, UNIT-DOSE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33408/12/2013
    Labeler - LLC Federal Solutions (965036895)
    Establishment
    NameAddressID/FEIBusiness Operations
    Safecor Health, LLC828269675repack(24451-788)
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

More Info on this Drug

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