Label: EPSOM SALT- magnesium sulfate granule

  • 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 April 25, 2020

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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 using 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

    age dose

    adults and children 2-4 level teaspoons dissolved

    12 years and older in a full glass (8oz) of water

    children 6 to 1-2 level teaspoons dissolved

    11 years in a full glass (8oz) of water

    Not recommended for children under 6 years of age

  • Inactive ingredients

    NONE

  • Other information

    ■ each teaspoon contains magnesium 493 mg

  • PRINCIPAL DISPLAY PANEL

    11140 EPSOM SALT

  • INGREDIENTS AND APPEARANCE
    EPSOM SALT 
    magnesium sulfate granule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43221-001
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM SULFATE, UNSPECIFIED FORM100 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    MAGNESIUM (UNII: I38ZP9992A)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43221-001-19544 g in 1 POUCH; Type 0: Not a Combination Product09/05/2016
    2NDC:43221-001-16454 g in 1 POUCH; Type 0: Not a Combination Product09/05/2016
    3NDC:43221-001-041810 g in 1 POUCH; Type 0: Not a Combination Product09/05/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33409/05/2016
    Labeler - Frog Prince(China)Daily Chemicals Co., Ltd. (529564476)
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