Label: ROYAL EPSOM SALT- magnesium sulfate granule, for solution

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 28, 2023

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  • OTHER SAFETY INFORMATION

    Tamper Evident: Do not use if the heat seal at the top of the package is improperly or not fully sealed.

  • Active ingredient

    Magnesium Sulfate

  • Purpose

    Laxative

  • Uses

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

  • Do no use

    • if you have kidney disease unless directed by a doctor
    • when abdominal pain, nausea, or vomiting are present unless directed by a doctor
    • for more than 1 week unless directed by a doctor
  • Ask a doctor before use if you have

    • kidney disease
    • a magnesium-restricted diet
    • noticed a sudden change in bowel habits that persists over a period of 2 week
  • Ask a doctor or pharmacist before use if you are

    taking a prescription drug. Take this product two or more hours before or after other drugs.

  • 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 help 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

    Directions

    Adults and children 12 years and over - Oral dosage is 10 to 30 grams

    children 6 to under 12 years of age - Oral dosage is 5 to 10 grams

    children 2 to under 6 years of age - Oral dosage is 2.5 to 5 grams

    children under 2 years of age - consult a doctor

    • Drink a full glass (8 ounces) of liquid with each dose.
    • The dose may be taken as a single daily dose or in divided doses.
    • 1 teaspoon equals 5 grams.
  • Other information

    • Magnesium content 495 mg per teaspoon (5 grams)
  • Inactive Ingredients

    none

  • Questions

    Questions or comments? 1-800-632-6900

  • Side panel information

    Store in cool, dry place out of direct

    sunlight. Package sold by weight not

    volume, some settling of contents may

    occur during shipment. If caking occurs,

    tap pouch gently to free granules.

    ROYAL

    Distributed by:

    Filo America Inc.

    Vernon, CA 90058

    United States

    Made in China

  • Principal display panel

    Royal

    Epsom Salt

    Magnesium Sulfate

    Saline Laxative

    Plain

    NET WT. 4 lbs (1.8 kg)

    Distributed by:

    Filo America Inc.

    Vernon, CA 90058

    United States

    Made in China

    NET WT. 4 lbs (1.8 kg)

    FrontBack

  • INGREDIENTS AND APPEARANCE
    ROYAL EPSOM SALT 
    magnesium sulfate granule, for solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50438-001
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM SULFATE, UNSPECIFIED FORM1 kg  in 1 kg
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50438-001-001.8 kg in 1 BAG; Type 0: Not a Combination Product10/29/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00710/29/2014
    Labeler - Filo America (943873703)
    Establishment
    NameAddressID/FEIBusiness Operations
    Hefei Yatai Daily-Use Chemical Industry Co., Ltd654641724manufacture(50438-001)
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