Label: EPSOM SALT- magnesium sulfate granule

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 November 14, 2017

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

  • Active ingredient

    Magnesium sulfate USP (heptahydrate) 100%

    Purpose

    Saline laxative

  • Uses

    •for relief of occasional constipation (irregularity)
    •this product generally produces bowel movement in 1/2 to 6 hours

  • WARNINGS

    Warnings

    Ask a doctor before use if you have
    •kidney disease
    •a magnesium-restricted diet
    •abdominal pain, nausea, or vomiting
    •noticed a sudden change in bowel habits that persists over a period of 2 weeks
    •already used a laxative for a period longer than 1 week

  • Ask a doctor or pharmacist before use if you are

    taking any other drug.  Take this product 2 or more hours before or after other drugs.  Laxatives may affect how other drugs work.

    Stop use and ask a doctor if

    you have rectal bleeding or failure to have a bowel movement after use. These could be signs of a serious condition.

    Keep out of reach of children.

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

  • Directions

    •do not exceed recommended daily dosage
    •drink a full glass (8 ounces) of liquid with each dose
    •may be taken as a single daily dose or in divided doses
    •dissolve the dose in 8 ounces of water.  lemon juice may be added to improve the taste

    adults and children 12 years and over - 2 to 6 level teaspoons (10 to 30 grams) daily
    children 6 to under 12 years - 1 to 2 level teaspoons (5 to 10 grams) daily
    children under 6 years - consult a doctor

  • Other information

    •magnesium content 495 mg per teaspoon (5 grams)

  • SPL UNCLASSIFIED SECTION

    Tamper evident Packaging:
    Caution: This package has been sealed for your protection. Do not use if package is open, torn or mutilated.

    For external use as a soaking aid for minor sprains and bruises
    Directions: Dissolve 2 cupfuls of tis product per gallon of water. Apply with bandages or toweling for 30 minutes up to three times a day, or use as a soak or in bath. Use warm water for best results.

    Directions for use (fertilizer)
    Or  for use as a fertilizer apply at the following rates:

    Lawns:
    Apply at a rate of 1/2 pound per one thousand square feet of lawn.

    Garden Plants and Shrubbery: Sprinkle 2 tablespoons around the base of each plant.

    For use as a plant food supplement apply at the following rates:

    Tomatoes, roses
    One teaspoon per foot plant height every two weeks.

    Evergreens, Azaleas, Rhododendrons.Apply one tablespoon per nine sq. Ft. (3' x 3') over the
    root zone every two to four weeks.

    Trees
    Apply two tablespoons per nine sq ft (3' x 3') over root zone once every four months

    Garden startupSprinkle approximately one cup per 100 sq.ft. (10' x 10') and mix into soil prior to planting.

    HouseplantsMix one teaspoon per gallon of water and feed to plants every one to four weeks

    For quicker results water plants after applying this product.

    Guaranteed Analysis
    Magnesium (Mg) .........................................9.8%
    9.8% Soluble Magnesium (Mg)
    Sulfur (S)......................................................12.9%
    12.9% Combined Sulfur (S)
    Derived from: magnesium sulfate
    F-1253

    Information regarding the contents and levels of metals in
    this product is available on the Internet at:
    http.//agr.wa.gov
    GUARANTEED BY: Vi-Jon, Inc
    8515 Page Ave.
    St. Louis, MO 63114

    Proudly Distributed by
    Western Family Foods, Inc
    PO Box 4507
    Portland, OR 97208

  • PRINCIPAL DISPLAY PANEL

    RESEALABLE
    Helps Keep Moisture Out
    WESTERN FAMILY
    Epsom Salt
    MAGNESIUM SULFATE U.S.P.
    •Soak Solution
      for minor sprains and bruises
    •Saline Laxative
    •Plant Nutrient

    Net Wt 1 LB (454 g)

    image of principal display panel

    029.003/602AA

  • INGREDIENTS AND APPEARANCE
    EPSOM SALT 
    magnesium sulfate granule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55312-029
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MAGNESIUM SULFATE HEPTAHYDRATE (UNII: SK47B8698T) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM SULFATE HEPTAHYDRATE100 kg  in 100 kg
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55312-029-071.81 kg in 1 POUCH; Type 0: Not a Combination Product06/05/1998
    2NDC:55312-029-43.454 kg in 1 POUCH; Type 0: Not a Combination Product06/05/1998
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33406/05/1998
    Labeler - Western Family (192166072)
    Registrant - Vi Jon (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi Jon790752542manufacture(55312-029)