Label: EPSOM SALT- magnesium sulfate granule

  • NDC Code(s): 36800-395-01, 36800-395-04, 36800-395-10, 36800-395-40
  • Packager: TOP CARE (Topco Associates LLC)
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated June 19, 2024

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  • Active ingredient

    Magnesium sulfate USP 100%

  • Purpose

     Saline laxative

  • Uses

    • relieves occasional constipation (irregularity)
    • generally produces bowel movement in 1/2 to 6 hours
  • Warnings

    Ask a doctor before use if you have

    • kidney disease
    • a magnesium restricted diet
    • stomach pain, nausea or vomiting
    • noticed a sudden change in bowel habits that lasts more than 2 weeks

    Ask a doctor or pharmacist before use if you are

     presently taking a prescription drug.

    When using this product

    • do not use more than directed

    Stop use and ask a doctor if

    • you have rectal bleeding or failure to have a bowel movement after use. This may indicate a serious condition.
    • you need to use a laxative for more than 1 week

    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 (1-800-222-1222) right away.

  • Directions

    • do not exceed more than 2 doses per day; if necessary repeat dosage in 4 hours
    agedose
     adults and children 12  years and older 2-4 level teaspoons dissolved in a full glass (8oz) of water 
     children 6 to 11 years

    1-2 level teaspoons in a full glass (8oz) of water

    Not recommended for children under 6 years of age.
  • Other information

    • each teaspoon contains: magnesium 495 mg
  • Inactive ingredient

     none

  • Principal Display Panel

    Epsom Salt

    MAGNESIUM SULFATE U.S.P.

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

    NET WT OZ (LB)

    TAMPER EVIDENT: DO NOT USE IF HEAT SEALED POUCH IS IMPROPERLY SEALED.

    DISTRIBUTED BY TOPCO ASSOCIATES LLC

    ELK GROVE VILLAGE, IL 60007

    topcare@topcare.com

    www.topcarebrand.com

  • Package Label

    Magnesium Sulfate USP 100%

    TOPCARE HEALTH Epsom Salt

  • INGREDIENTS AND APPEARANCE
    EPSOM SALT 
    magnesium sulfate granule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-395
    Route of AdministrationORAL, TOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM SULFATE, UNSPECIFIED1 g  in 1 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:36800-395-01454 g in 1 CARTON; Type 0: Not a Combination Product04/30/2014
    2NDC:36800-395-041810 g in 1 CARTON; Type 0: Not a Combination Product04/30/2014
    3NDC:36800-395-10454 g in 1 POUCH; Type 0: Not a Combination Product04/30/2014
    4NDC:36800-395-401814 g in 1 POUCH; Type 0: Not a Combination Product04/30/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00704/30/2014
    Labeler - TOP CARE (Topco Associates LLC) (006935977)
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