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

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 December 16, 2022

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

View All Sections
  • Active ingredient

    Magnesium sulfate USP ( Heptahydrate) 100%

  • purpose

    Saline laxative

  • 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.

  • 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.

  • 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.

  • If pregnant or breast-feeding

    ask a health professional before use.

  • 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

    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.

  • inactive ingredients

    None

  • Other information

    • magnesium content 495 mg per teaspoon (5 grams)
  • ADVERSE REACTIONS

    Tamper Evident Packaging:

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

    Cut along dotted line and press zipper to reseal

    DISTRIBUTED BY TOPCO ASSOCIATES, LLC

    ELK GROVE VILLAGE, IL 60007

    1-888-423-0139

    topcare@topco@com

    602.002/602AA

  • principal display panel

    Cut along dotted line and press zipper to reseal.

    TopCare health

    Epsom

    Salt

    MAGNESIUM SULFATE U.S.P.

    • Saline Laxative for Relief of Occasional Constipation
    • Soaking Aid for Minor Sprains and Bruises

    NEW WT 64OZ (4 LB) 1.81 kg

    image description

  • INGREDIENTS AND APPEARANCE
    EPSOM SALT 
    magnesium sulfate granule, for solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-602
    Route of AdministrationORAL, TOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MAGNESIUM SULFATE HEPTAHYDRATE (UNII: SK47B8698T) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM SULFATE HEPTAHYDRATE1 g  in 1 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:36800-602-43454 g in 1 POUCH; Type 0: Not a Combination Product07/15/1999
    2NDC:36800-602-071814 g in 1 POUCH; Type 0: Not a Combination Product07/15/1999
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33407/15/1999
    Labeler - TOPCO Associates, LLC (006935977)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(36800-602)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials

More Info on this Drug

Get Label RSS Feed, View NDC Code(s)NEW!