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 February 8, 2021

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

  • Active ingredient

    Magnesium sulfate USP ( Heptahydrate) 100%

  • Purpose

    Saline laxative

  • Uses

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

    Warnings

  • 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.
  • 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

    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 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

  • Other information

    Other information

    • magnesium content 495 mg per teaspoon (5 grams)
  • SPL UNCLASSIFIED SECTION

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

    Drug Mart
    EPSOM SALT
    MAGNESIUM SULFATE U.S.P.
    MgSO4 - 7H2O

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

    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.

    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.

    Distributed By:C.D.M.A., Inc

    43157 W 9 mile Rd

    Novi, MI 48375

    www. qualitychoice.com

    Questions: 800-935-2362

  • principal display panel

    Cut along dotted line and press zipper to reseal.

    QC

    QUALITY

    CHOICE

    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 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:63868-602
    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:63868-602-071814 g in 1 POUCH; Type 0: Not a Combination Product12/02/2019
    2NDC:63868-602-43454 g in 1 POUCH; Type 0: Not a Combination Product12/02/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33412/02/2019
    Labeler - C.D.M.A. (011920774)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(63868-602)