Label: EPSOM SALT- magnesium sulfate heptahydrate granule, for solution 

  • NDC Code(s): 37012-602-07
  • Packager: ShopKo Stores Operating Co., LLC
  • 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 07/13

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

  • To Open

    Cut along dotted line and press zipper to reseal

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  • Active ingredient

    Magnesium sulfate USP ( Heptahydrate) 100%

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  • purpose

    Saline laxative

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  • Uses

    Uses for Oral Laxative

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

    For Soaking

    For external use as a soaking aid for minor sprains and bruises.

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  • Warnings

    Warnings for Soaking

    CAUTION: If prompt relief is not obtained or there is evidence of infection, discontinue use and consult your physician. Hot or warm soaks should not be used by individuals with diabetes except on the advice of a physician. Keep out of reach of children.

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  • 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.
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  • 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.

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  • 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.

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  • If pregnant or breast-feeding

    ask a health professional before use.

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  • Keep out of reach of children

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

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  • directions

    • do not exceed recommended daily dosage
    • drink a full glass (8 ounces) of liquie 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

    Directions for Soaking

    Directions: Dissolve 2 cupfuls of this product per gallon of water. Apply with bandages or towelling for 30 minutes up to three times a day, or use as a soak or in bath. Use warm water for best results.

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  • Other information

    Other information

    • magnesium content 495 mg per teaspoon (5 grams)
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  • Adverse reaction section

    Packaged by Vi-Jon, Inc.

    One Swan Dr., Smyrna, TN 37167

    For ShopKo Stores Operating Co., LLC

    www.shopko.com

    For consumer questions

    call 1-888-593-0593

    SHOPKO

    Satisfaction

    Guaranteed

    By Refund Or Exchange

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  • Principal Display Panel

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

    Zip to reseal  helps keep moisture out

    SHOPKO

    Epsom Salt

    Magnesium Sulfate USP

    MgSO4 7H2O

    Soaking Aid

    For Minor Sprains and Bruises

    Saline Laxative

    For relief of Occasional Constipation

    Net Wt 4 LB ( 1.81 kg)

    image description

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  • INGREDIENTS AND APPEARANCE
    EPSOM SALT 
    magnesium sulfate granule, for solution
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:37012-602
    Route of Administration ORAL, TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MAGNESIUM SULFATE HEPTAHYDRATE (MAGNESIUM CATION) MAGNESIUM SULFATE HEPTAHYDRATE 1 g  in 1 g
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:37012-602-07 1814 g in 1 POUCH
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part334 06/05/2009
    Labeler - ShopKo Stores Operating Co., LLC (023252638)
    Registrant - Vi-Jon (790752542)
    Establishment
    Name Address ID/FEI Business Operations
    Vi-Jon 790752542 manufacture(37012-602)
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