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
  • 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

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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 not finalpart33404/30/2014
    Labeler - TOP CARE (Topco Associates LLC) (006935977)
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