Label: EPSOM SALT granule

  • NDC Code(s): 49580-0394-1, 49580-0394-2, 49580-0394-4, 49580-0394-8
  • Packager: P & L Development, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated April 15, 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 pregnancy 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 older2-4 level teaspoons dissolved in a full glass (8oz) of water 
     children 6 to 11 years

    1-2 level teaspoons dissolved 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 

  • Questions or comments?

    For laxative or soak, call 1-877-753-3935 Monday- Friday 9AM-5PM EST

  • Principal Display Panel

    EPSOM SALTS

    MAGNESIUM SULFATE

    SALINE LAXATIVE

    • Relieves occasional constipation
    • Soaking aid for minor sprains and bruises

    Net Wt LB (kg)

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

    Distributed by:

    PL Developments, 1874 Hwy 72 W

    Clinton, SC 29325

  • Package Label

    Magnesium Sulfate USP 100%

    WHITE MOUNTAIN Epsom Salt

  • INGREDIENTS AND APPEARANCE
    EPSOM SALT 
    epsom salt granule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49580-0394
    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:49580-0394-41814 g in 1 POUCH; Type 0: Not a Combination Product12/31/2017
    2NDC:49580-0394-1454 g in 1 POUCH; Type 0: Not a Combination Product12/31/2017
    3NDC:49580-0394-2907 g in 1 POUCH; Type 0: Not a Combination Product12/31/2017
    4NDC:49580-0394-83628 g in 1 POUCH; Type 0: Not a Combination Product12/31/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00712/31/2017
    Labeler - P & L Development, LLC (101896231)
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