Label: EPSOM SALT- magnesium sulfate granule, for solution

  • NDC Code(s): 83324-175-04, 83324-175-16
  • Packager: C.D.M.A.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated March 13, 2025

If you are a consumer or patient please visit this version.

  • Tamper Evident Statement

    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

    • for relief of occasional constipation (irregularity)
    • this product generally produces bowel movement in 1/2 to 6 hours
  • Warnings

    for this product

  • 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

    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
  • Inactive ingredient

    None

  • Claims

    Epsom Salt

    Saline Laxitive

    Magnesium Sulfate U.S.P.

    MgSO • 7H 2O

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

    Directions: For a relaxing bath/soak, generously sprinkle Epsom Salt into warm, running bath water.

    CAUTION: If prompt relief is not obtained or there is evidence of infection, 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.

  • Adverse reaction

    SATISFACTION GUARANTEED

    100% QC

    Distributed By:CDMA, Inc.

    Novi, MI 48375

    www. qualitychoice.com

    Questions: 800-935-2362

  • Principal display panel

    Cut along dotted line and press zipper to reseal.

    NDC 83324-175-16

    QC ®

    QUALITY

    CHOICE

    Epsom

    Salt

    Saline Laxative

    Magnesium Sulfate U.S.P.

    MgSO 4  • 7H 2O

    Saline Laxative

    For Relief of Occasional Constipation

    Soaking Aid

    For Minor Sprains and Bruises

    NET WT 1 LB (454 g)

    image description

  • INGREDIENTS AND APPEARANCE
    EPSOM SALT 
    magnesium sulfate granule, for solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83324-175
    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:83324-175-16454 g in 1 POUCH; Type 0: Not a Combination Product07/02/2024
    2NDC:83324-175-041814 g in 1 POUCH; Type 0: Not a Combination Product07/02/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00707/02/2024
    Labeler - C.D.M.A. (011920774)
    Registrant - Consumer Product Partners, LLC (119091520)
    Establishment
    NameAddressID/FEIBusiness Operations
    Consumer Product Partners, LLC119091514manufacture(83324-175)