Label: EPSOM SALTS- magnesium sulfate granule

  • NDC Code(s): 52862-202-01
  • Packager: International Wholesale Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 19, 2024

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

  • ACTIVE INGREDIENT

    Active Ingredients Purpose

    Magnesium Sulfate (heptahydrate) 100% Saline Laxative

  • PURPOSE

    Uses

    • For relief of Occasional Constipation (Irregularity)
    • This product generally produces bowel movement
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

  • INDICATIONS & USAGE

    Ask a doctor or pharmacist before use if you are taking any other drug. Take this product 2 or more hours before or after any other drugs. Laxative may affect how other drugs work.

  • 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 of longer than 1 week

    If pregnant or breast-feeding ask a health profesional before use

  • DOSAGE & ADMINISTRATION

    Directions

    • do not exceed more than 2 doses per day
    • drink a full glass (8 ounces) of liquid with each dose
    • 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 4 level teaspoons (10 to 20 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
  • INACTIVE INGREDIENT

    There are no inactive ingredients

  • PRINCIPAL DISPLAY PANEL

    Health Smart

    Mutli purpose

    Epsom Salts

    Net Wt. 16 oz (454 g)

    Label

  • INGREDIENTS AND APPEARANCE
    EPSOM SALTS 
    magnesium sulfate granule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52862-202
    Route of AdministrationTOPICAL, ORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MAGNESIUM SULFATE HEPTAHYDRATE (UNII: SK47B8698T) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM SULFATE HEPTAHYDRATE100 g  in 100 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52862-202-01454 g in 1 POUCH; Type 0: Not a Combination Product07/09/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01707/09/2019
    Labeler - International Wholesale Inc. (161872676)
    Registrant - Jell Pharmaceuticals Pvt. Ltd. (726025211)
    Establishment
    NameAddressID/FEIBusiness Operations
    Jell Pharmaceuticals Pvt. Ltd.726025211manufacture(52862-202)