Label: EPSOM SALT- magnesium sulfate granule, for solution

  • NDC Code(s): 50594-602-01
  • Packager: Meijer Distribution, Inc
  • 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 December 16, 2022

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 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.  (1-800-222-1222) immediately.

  • 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

  • inactive ingredients

    none

  • 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 mulitated.

    Epsom Salt is a trusted remedy that is useful every season of the year
    BEAT WINTER BLUES - Simply dissolve two cups of epsom salt in a warm bath to: -reduce stifness and soreness in joints - warmand comfort your muscle aches
    A MINERAL SPRING SPA - Springtime is your fresh start to working out ofter leadng to overexertion. Just dissolve two cups of epsom salt in warm bat water, settle in, and experience the relief and relaxation.
    FIRST AID SUMMER SALT - Dissolve two cups of epsom salt per gallon of water to make a compress. Apply as wet dressing with towel to:
    relieve stiffness and sorness.
    warm and comfort yor muscles aches
    RELAX INTO AUTUMN - By dissolving two cups of epsom salt in a gallon of warm water, you'll be able to:
    soak away tiredness and soreness
    help soothe away stress

    Directions: Dissolve 2 cups of this product per galon of water. Apply with bandages or toweling for 30 minutes up to three times a day, or use as a soak or in a 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 warms soaks should not be used by individuals with diabetes except on the advice of a physican.

    For external use as a soaking aid for minor sprains and bruises
    Discover the Relaxing Spa-Like Qualities of This Product in Your Bath

    Distributed by: Vi: Jon

    8515 Page Avenue

    St. Louis, MO 63114

    V#425040  Item# 602

  • principal panel display

    SOUND BODY

    Epsom Salt

    Magnesium Sulfate U.S.P.

    MgSO4 - 7H20

    Saline Laxative

    For Relief of Occasional Constipation

    Soaking Aid

    For Minor Sprains and Bruises

    Discover the Relaxing Spa-Like Qualities of This Product in Your Bath

    NET WT 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:50594-602
    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:50594-602-011814 g in 1 POUCH; Type 0: Not a Combination Product07/21/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33407/21/2015
    Labeler - Meijer Distribution, Inc (017885351)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(50594-602)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC088520668manufacture(50594-602)