Label: MILK OF MAGNESIA suspension

  • Category: HUMAN OTC DRUG LABEL

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Drug Label Information

Updated December 22, 2022

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  • 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 over

    5 to 15 mL (1 to 3 teaspoonfuls)

    children under 12 years of age

    ask 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 older

    30 mL (2 TBSP) to 60 mL (4 TBSP)

    children 6 – 11 years

    15 mL (1 TBSP) to 30 mL (2 TBSP)

    children under 6 years

    ask 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:

    Overbagged with 5 x 30 mL unit dose cups in each bag, NDC 55154-9403-5.
  • 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

    Distributed by:

    Cardinal Health

    Dublin, OH 43017

    L33325171020

  • Principal Display Panel

    Milk of Magnesia USP

    5 Cups

    bag label
  • INGREDIENTS AND APPEARANCE
    MILK OF MAGNESIA 
    milk of magnesia suspension
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55154-9403(NDC:0121-0431)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (HYDROXIDE ION - UNII:9159UV381P) MAGNESIUM HYDROXIDE2400 mg  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POTASSIUM CITRATE (UNII: EE90ONI6FF)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorSPEARMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55154-9403-55 in 1 BAG06/07/2011
    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 finalpart33106/07/2011
    Labeler - Cardinal Health 107, LLC (118546603)
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