Label: ASSURED EPSOM SALT- magnesium sulfate granule

  • 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 February 11, 2019

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  • 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 in 1/2 to 6 hours
  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN

    If pregnant or bread feeding, aska a health professional before use. 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 your are taking any other drug. Take this product 2  or more hours before or after other drugs. Laxatives 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 longer than 1 week
  • 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 year  - 1 to 2 level teaspoons (5 to 10 grams) daily

    children under 6 year - consult a doctor

  • INACTIVE INGREDIENT

    None Available

  • PRINCIPAL DISPLAY PANEL

    Back labelFront label

    Assured

    Multi-Purpose

    Epsom Salt

    Natural Magnesium Sulfate

    All Natural

    Net WT 16 OZ (454g)

  • INGREDIENTS AND APPEARANCE
    ASSURED EPSOM SALT 
    magnesium sulfate granule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:33992-3020
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MAGNESIUM SULFATE HEPTAHYDRATE (UNII: SK47B8698T) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM SULFATE HEPTAHYDRATE100 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    SULFUR (UNII: 70FD1KFU70)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:33992-3020-1454 g in 1 BAG; Type 0: Not a Combination Product06/14/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33406/14/2016
    Labeler - Greenbrier International, Inc. (610322518)
    Establishment
    NameAddressID/FEIBusiness Operations
    Greenbrier International, Inc.529047265manufacture(33992-3020)
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