Label: EPSOM SALT- magnesium sulfate granule, for solution

  • NDC Code(s): 30142-602-07, 30142-602-43
  • Packager: Kroger Co.
  • 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 May 13, 2016

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

  • TEP Statement

    Tamper Evident Packaging

    Caution: this package has been sealed for your protection.

    Do not use if package is open, torn or mulitated

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  • Active ingredient

    Magnesium sulfate USP (heptahydrate) 100%

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  • Purpose

    Saline Laxative

    Soaking aid

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  • Use

    Uses for Laxative

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

    Uses for Soaking Aid

    • for minor sprains and bruises
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  • Warnings

    Caution: if prompt relief is not obtained or there is evidence of infection, discontinue use and consult your phyusician. ot 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

    • 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. Laxativs 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 help 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 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

    DIRECTIONS: Dissolve 2 cupfuls of this 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

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  • Other information

    • magnesium content 495 mg per teaspoon (5 grams)
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  • Questions

    Questions or comments? 1-800-632-6900

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  • Adverse Reactions

    DISTRIBUTED BY THE KROGER CO.

    CINCINNATI, OHIO 45202

    QUALITY GUARANTEE

    www.kroger.com

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  • Side panel claims

    epsom salt

    MAGNESIUM SULFATE U.S.P.

    MgSO4  7H2O

    For esternal use as a soaking aid

    for minor sprains and bruises

    Kroger

    FROM OUR FAMILY

    TO YOURS

    epsom salt

    MAGNESIUM SULFATE U.S.P.

    MgSO4 - 7H2O

    Your Wellness Mentor

    Adding Epsom salt to your bath will help relieve

    the aches and pains of minor spains and bruises.

    Let Epsom salt do the work while you relax in

    the bathtub.

    Kroger Brand Cares for Us Every Day

    Restored and protected, that's how we help you

    feel confident in caring for the most important

    people in your life.  Kroger Brand products: here to

    help you with what really matters.

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  • Adverse Reactions Section

    DISTRIBUTED BY THE KROGER CO.

    CINCINATI, OHIO 45202

    QUALITY GUARANTT

    www.kroger.com

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  • Package label

    Cut along dotted line and press zipper to reseal.

    Kroger

    FROM OUR FAMILY

    TO YOURS

    epsom salt

    MAGNESIUM SULFATE U.S.P.

    MgSO4  7H2O

    SALINE LAXATIVE

    For Relief of Occasional

    Constipation

    SOAKING AID

    For Minor Sprains and Bruises

    NET WT 4 LB

    (64 OZ) 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 Item Code (Source) NDC:30142-602
    Route of Administration ORAL, TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MAGNESIUM SULFATE HEPTAHYDRATE (UNII: SK47B8698T) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM SULFATE HEPTAHYDRATE 1 g  in 1 g
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:30142-602-43 453 g in 1 POUCH; Type 0: Not a Combination Product 10/21/1993
    2 NDC:30142-602-07 1814 g in 1 POUCH; Type 0: Not a Combination Product 10/21/1993
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part334 10/21/1993
    Labeler - Kroger Co. (006999528)
    Registrant - Vi-Jon (790752542)
    Establishment
    Name Address ID/FEI Business Operations
    Vi-Jon 790752542 manufacture(30142-602)
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