Label: EPSOM SALT- magnesium sulfate granule

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 06/12

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

  • Active ingredient

    Magnesium Sulfate USP (epsom salt)

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  • Purpose

    saline laxative

    soaking solution

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  • Uses

    Internal

    relieves occasional constipation (irregularity)

    generally produces bowel movement in 1/2 to 6 hours

    External

    relieves pain from minor sprains and bruises

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  • Warnings

    ask a doctor before use if you have

    kidney disease
    a magnesium restricted diet


    stomach pain,  nausea or vomiting
    noticed a sudden change in bowel habits that lasts more than one week


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  • Ask a doctor or pharmacist before use if you are

    presently taking a prescription drug

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  • when using this product

    do not use more than directed.

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  • Stop use and ask a doctor if

    As a laxative,

    you have rectal bleeding or no bowel movement after use .

    These could be a sign of a serious condition.

    you need to use a laxative more than one week.

    As a soaking solution,

    you have redness, irritation, swelling, or infection occurs.

    hot or warm soaks should not be used by individuals with diabetes except with the advice of a physician.



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  • If pregnant or breast feeding

    ask a health professional before use.

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  • keep this and all drugs out of the reach of children.

    In case of accidental overdose, seek professional assistance or contact a poison control center immediately.
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  • Directions

    For Internal Use as a laxative

    Adults and Children 12 years of age and older            2-4 level teaspoons dissolved in a full glass (8oz) of water.                                                                                                                   

    children 6 to under 12 years                                     1-2 level teaspoons dissolved in a full glass (8oz) of water.


    not recommended for children under 6 years of age.

    For External Use as a soaking solution

    Adults dissolve 1/2 cup in a quart of water, and apply wet, with towel, etc.

    As a bathing solution,

    2 cups added to the bath water for a refreshing bath after strenuous exertion.


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  • principal display panel
  • INACTIVE INGREDIENT

    None

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  • INGREDIENTS AND APPEARANCE
    EPSOM SALT 
    magnesium sulfate crystal granule
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:63777-204
    Route of Administration ORAL, TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MAGNESIUM SULFATE (MAGNESIUM CATION) MAGNESIUM SULFATE 1.81 kg  in 100 kg
    Inactive Ingredients
    Ingredient Name Strength
    SULFIDE ION  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:63777-204-01 .454 kg in 1 CARTON
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part334 06/14/2012
    Labeler - Kinray, Inc. (012574513)
    Registrant - Aaron Industries, Inc. (030119387)
    Establishment
    Name Address ID/FEI Business Operations
    Aaron Industries, Inc. 030119387 api manufacture(63777-204), analysis(63777-204), label(63777-204)
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