Label: EPSOM SALT- magnesium sulfate crystal

  • NDC Code(s): 70000-0021-1, 70000-0021-2
  • Packager: Cardinal Health, 110 dba Leader
  • 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 November 10, 2022

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  • SAFETY SEAL

    TAMPER EVIDENT PACKAGING:

    CAUTION: THIS PACKAGE HAS BEEN SEALED FOR YOUR PROTECTION.

    DO NOT USE IF PACKAGE IS OPEN, TORN OR MUTILATED

  • Active ingredient

    Magnesium sulfate USP (heptahydrate)100%

  • Purpose

    Saline Laxative

  • Uses

    Uses for Oral Laxative

    • for relief of occasional constipation (irregularity)
    • this product 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
    • abdominal pain, nausea, or vomiting
    • noticed a sudden change in bowel habits that persists over a period of 2 weeks
    • already used a laxative for a period longer than 1 week
  • Ask a doctor or pharmacist before use if you are

    taking any other drug. Take this product 2 or more hours before or after other drugs. Laxatives may affect how other drugs work.

  • Stop use and ask a doctor if

    you have rectal bleeding or failure to have a bowel movement after use. These could be signs of a serious condition.

  • 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 right away.

  • Directions

    • do not exceed recommended daily dosage
    • drink a full glass (8 ounces) of liquid with each dose
    • may be taken as a single daily dose or in divided doses
    • dissolve the dose in 8 ounces of water. Lemon juice may be added to improve the taste.

    adults and children 12 years and over - 2 to 6 level teaspoons (10 to 30 grams) daily

    children 6 to under 12 years - 1 to 2 level teaspoons (5 to 10 grams) daily

    children under 6 years - consult a doctor

  • Other information

    • each teaspoon (5 grams) contains: magnesium 495 mg
  • claims

    For external use as a soaking aid for minor sprains and bruises.

    Directions: {For a relaxing bath/soak,} generously {or liberally} sprinkle  {or pour} LEADER Epsom Salt into warm, running bath water

    Caution: IF  PROMPT RELIEF IS NOT OBTAINED OR THERE IS EVIDENE OF INFECITION, DISCONTINUE USE AND CONSULT YOUR PHYSICIAN.  HOT OR WARM SOAKS SHOULD NOT BE USED BY INDIVIDUALS WITH DIABETES EXCEPT ON THE ADVICE OF A PHYSICIAN.  KEEP OUT OF REACH OF CHILDREN.

  • Inactive Ingredients

    None

  • Question and comments?

    1-800-593-0593

  • Adverse reactions section

    Cardinal Health

    DISTRIBUTED BY

    CARDINAL HEALTH

    DUBLIN, OHIO 43017

    www.myleader.com

    1800-200-6313

    Essential to Care since 1979

    2019 Cardinal Health.  All Rights Reserved.  CARDINAL HEALTH, the Cardinal Health LOGO, LEADER and the Leader LOGO are trademarks or registered trademarks of Cardinal Health.

     ALL LEADER Brand Product Have A 100% Money Back Guarantee

    Return to place of purchase if not satisfied

    CIN 5516083  REV 4/19

  • principal display panel

    CUT ALONG DOTTED LINE AND PRESS ZIPPER TO RESEAL

    LEADER

    NDC 70000-0021-1

    EPSOM

    SALT

    Magnesium Sulfate USP, 100%

    Saline Laxative

    Saine Laxative

    For Relief of Occasional

    Constipation

    Soaking Aid

    For Minor Sprains

    and Bruises

    100% Money

    Back Guarantee

    Net WT 1 LB (454 g)

    image description

  • INGREDIENTS AND APPEARANCE
    EPSOM SALT 
    magnesium sulfate crystal
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0021
    Route of AdministrationORAL, TOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MAGNESIUM SULFATE HEPTAHYDRATE (UNII: SK47B8698T) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM SULFATE HEPTAHYDRATE1 g  in 1 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70000-0021-21814 g in 1 POUCH; Type 0: Not a Combination Product03/26/2012
    2NDC:70000-0021-1454 g in 1 POUCH; Type 0: Not a Combination Product03/26/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33403/26/2012
    Labeler - Cardinal Health, 110 dba Leader (063997360)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(70000-0021)
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