Label: EPSOM SALT- magnesium sulfate granule, for solution

  • NDC Code(s): 69842-602-04, 69842-602-07, 69842-602-80
  • Packager: CVS Pharmacy
  • 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 June 6, 2022

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  • 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

    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

    • magnesium content 495 mg per teaspoon (5 grams)
  • Inactive Ingredient

    None

  • SPL UNCLASSIFIED SECTION

    Tamper Evident Packaging:
    Caution: this package has been sealed for your protection. Do not use if package is open, torn or mutilated

    Epsom Salt is a trusted remedy that is useful every season of the year.

    Beat winter blues

    Simply dissolve two cups of epsom salt in a warm bath to:
    • Reduce stiffness and soreness
    • Warm and comfort your muscle aches

    A mineral spring spa

    Springtime is your fresh start to working out, oftentimes leading to overexertion. Just dissolve two cups of epsom salt in warm bath water, settle in, and experience the relief and relaxation.

    First aid summer salts
    Dissolve two cups of epsom salt in two cups of hot water to make a compress.
    Apply as a wet dressing with towel to:
    • Provide soothing relief from over exertion from sports
    • Warm and comfort your muscle aches

    Relax into autumn
    By dissolving two cups of epsom salt in a warm bath, you'll be able to:
    • Soak away tiredness and soreness
    • Help soothe away stress

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

    Directions: Dissolve 2 cupfuls of this product per gallon of water. Apply with bandages or toweling for 30 minutes up to three times a day. For a less intensive soak, use 1 or 2 cupfuls in a bath. Use warm water for best results.

    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.

    Distributed by: CVS Pharmacy, Inc.
    One CVS Drive, Woonsocket, RI 02895
    © 2016 CVS/pharmacy
    CVS.com® 1-800-SHOP CVS
    Made in the U.S.A. with U.S. and foreign components

  • principal display panel

    Value Size 8 lb

    CVS Health

    Epsom Salt

    Magnesium Sulfate USP

    Saline Laxative

    For external use as a soaking solution

    For minor sprains and bruises

    NET WT 8 LBS (3.62 kg)

    image description

  • INGREDIENTS AND APPEARANCE
    EPSOM SALT 
    magnesium sulfate granule, for solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-602
    Route of AdministrationORAL
    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:69842-602-803620 g in 1 POUCH; Type 0: Not a Combination Product07/15/1998
    2NDC:69842-602-042720 g in 1 POUCH; Type 0: Not a Combination Product07/15/1998
    3NDC:69842-602-071810 g in 1 POUCH; Type 0: Not a Combination Product07/15/1998
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33407/15/1998
    Labeler - CVS Pharmacy (062312574)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(69842-602)