Label: EPSOM SALT- magnesium sulfate granule, for solution

  • NDC Code(s): 36800-602-07, 36800-602-43
  • Packager: TOPCO Associates, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 01/13

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

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  • TEP

    Tamper Evident Packaging:

    Caution: This package has been sealed for your protection. do not use if package is open, torn or multiated

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  • Active ingredient

    Active ingredient

    Magnesium sulfate USP ( Heptahydrate) 100%

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  • purpose

    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

    Ask a doctor before use if you have

    • kidney disease
    • a magnesium-restricted diet
    • abdominal pail, 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

    Ask a doctor or pharmacist befoe 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

    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

    If pregnant or breast-feeding, ask a health professional before use.

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  • Keep out of reach of children

    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

    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

    DISTRIBUTED BY TOPCO ASSOCIATES, LLC

    ELK GROVE VILLAGE, IL60007

    1-888-423-0139

    topcare@topco@com

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  • Principal display panel

    TOPCARE

    Epsom

    Salt

    MAGNESIUM SULFATE U.S.P.

    MGSO4 - 7H20

    Saline Laxative

    • For relief of Occasional Constipation

    Soaking Aid

    • For Minor Sprains and Bruises

    NET WT 16 OZ (1 LB) 454 g

    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:36800-602
    Route of Administration ORAL, TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MAGNESIUM SULFATE (MAGNESIUM CATION) MAGNESIUM SULFATE 1 g  in 1 g
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:36800-602-43 454 g in 1 POUCH
    2 NDC:36800-602-07 1814 g in 1 POUCH
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part334 07/15/1999
    Labeler - TOPCO Associates, LLC (006935977)
    Registrant - Vi-Jon (790752542)
    Establishment
    Name Address ID/FEI Business Operations
    Vi-Jon 790752542 manufacture(36800-602)
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