Label: EPSOM SALT- magnesium sulfate granule, for solution

  • 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 15, 2015

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

View All Sections
  • TEP

    Tamper Evident Packaging:

    Caution: this package has been sealed for your protection.

    Do not use if package is open, torn or mutilated

  • Claims

    Epsom Salt

    Magnesium Sulfate U.S.P.

    MgSO4 - 7H2O

  • Active ingredient

    Magnesium sulfate USP (heptahydrate) 100%

  • Purpose

    Saline Laxative

    External use soaking aid

  • Uses

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

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

  • Warnings

    CAUTION: If prompt relief is not obtained or there is evidence of infection, discontinue use and consult your physician.

    Hot or warms soaks should not be used by individuals with diabetes except on the advice of a physican

  • 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:

    Dissolve 2 cups of CareOne Epsom Salt per fallon of water.  Apply with bandages or toweling for 30 minutes up to three times a day.  For less intensive soak, use 1 or 2 cups in a bath.  Use warm water for best results

  • Other information

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

    DISTRIBUTED BY:

    FOODHOLD U.S.A., LLC

    LANDOVER, MD 20785

    Quality Guaranteed or your money back.

  • principal display panel

    CAREONE

    EPSOM

    SALKT

    MAGNESIUM SULFATE U.S.P.

    • SALINE LAXATIVE
    • SOAKING AID

    For relief of occasional constipation

    For minor sprains and bruises

    NET WT 16 OZ

    (1 LB) 454 g

    image description

  • INGREDIENTS AND APPEARANCE
    EPSOM SALT 
    magnesium sulfate granule, for solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-055
    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:41520-055-43454 g in 1 POUCH; Type 0: Not a Combination Product
    2NDC:41520-055-071814 g in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33405/06/2015
    Labeler - FOODHOLD U.S.A., LLC (809183973)
    Registrant - Vi-Jon (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon790752542manufacture(41520-055)
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, PubMed, Biochemical Data Summary

More Info on this Drug

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