Label: HUMCO EPSON SALT- magnesium sulfate powder, for solution

  • NDC Code(s): 0395-0807-16, 0395-0807-94
  • Packager: Humco Holding Group, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 15, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Magnesium Sulfate (heptahydrate) 100%

  • Puropose

    Laxative/Soak solution

  • Use

    As a laxative: For relief of occasional constipation.

    As an external soaking aid: For temporary relief of minor sprains and bruises.

  • Warnings

    Ask as a doctor before use if you:

    haeve kidney disease or diabetes. Have abdominal pain, nausea, vomiting, change in bowel habits persisting more than 2 weeks. Have already used a laxative for a period longer than 1 week.

    Serious side effects from prolonged use or overdose may occur.

    Are taking prescription drugs.

  • Stop use and consult a doctor if

    When taking as laxative, there is rectal bleeding or failure to have a bowel movement after use. These could be signs of a serious condition.

    When using as soaking aid, discontinue use where promt relief is not obtained or where there is evidence of infection. Hot or warm soaks should not be used by individuals with diabetes except on the advice of a physician.

    If pregnant or breasfeeding, ask a health professional before use.

  • Keep out of reach of children.

    In case of accidental overdose, seek preofessional assistance or contact Poison Control Center immediately.

  • Directions

    For laxative use. Adults and children 12 yrs. of age and older:  2 to 4 level tsps (10 - 30 g) in an 8 oz glass of water. Repeat in 6 hours if needed. Drink 8 ozs of liquid with each dose. limit 2 doses per day. Lemon juice may be added to improve taste. this product generally produces bowel movements in 1/2 to 6 hours. Best when taken on an empty stomach.

    Children 6 to 12 yrs of age: Consulta doctor before use.

    For use as a soaking aid: Dissolve 2 cupfuls of Epson Salt per gallon of warm water. apply in conjunction with bandages or toweling.

  • Inactive ingredient

    None

  • Principal display panel

    capture

  • INGREDIENTS AND APPEARANCE
    HUMCO EPSON SALT 
    magnesium sulfate powder, for solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0395-0807
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MAGNESIUM SULFATE HEPTAHYDRATE (UNII: SK47B8698T) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM SULFATE HEPTAHYDRATE1000 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0395-0807-94113 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/13/2017
    2NDC:0395-0807-16454 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/13/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00703/25/1998
    Labeler - Humco Holding Group, Inc. (825672884)
    Registrant - Pharma Nobis, LLC (118564114)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharma Nobis, LLC118564114manufacture(0395-0807) , analysis(0395-0807) , pack(0395-0807) , label(0395-0807)