Label: MAGNESIUM CITRATE liquid

  • 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 3, 2020

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

  • Active ingredient

    Magnesium citrate 1.745 g per fl oz

  • Purpose

    Saline Laxative

  • Use

    for relief of occasional constipation (irregularity).  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 or potassium-restricted diet
    • abdominal pain or 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.

  • Other information

    Store at temperatures between 46° and 86° F (8° and 30° C)

  • Directions

    • drink a full glass ( 8 ounces) of liquid with each dose
    • may be taken as a single daily dose or in divided doses

    adults and children 12 years of age and over   -  6.5 to 10 fl oz maximum 10 fl oz in 24 hours

    children 6 to under 12 years of age  - 3 to 7 fl oz maximum 7 fl oz in 24 hours

    children 2 to under 6 years of age  - 2 to 3 maximum 3 fl oz in 24 hours

    children under 2 years of age - ask a doctor

    discad unused product withing 24 hours of opening bottle

  • Other information

    •  each fl oz contains: magnesium 290 mg
    •  each fl oz contains: potassium 80 mg
  • Inactive ingredients

    citric acid, lemon oil, potassium bicarbonate,  purified water, sodium saccharin

  • Adverse Reaction

    DISTRIBUTED BY CARDNAL HEALTH, DUBLIN, OHIO 43017

     www.myleader.com    1-800-260-6313

    686.001/686AF

  • principal display panel

    DO NOT USE IF TAMPER EVIDENT TWIST-OFF CAP IS MISSING, BROKEN OR SEPARATED FROM NECKRING

    NDC 37205-362-38

    LEADER

    Very Low Sodium

    Magnesium

    Citrate

    Oral Dolution

    Saline Laxative

    Lemon Flavor

    Pasteurized - The Sparkling Laxative

    SATISFACTION

    GUARANTEED

    10 FL OZ (296 mL)

    image description

  • INGREDIENTS AND APPEARANCE
    MAGNESIUM CITRATE 
    magnesium citrate liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37205-362
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MAGNESIUM CITRATE (UNII: RHO26O1T9V) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM CITRATE1.745 g  in 29.6 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    LEMON (UNII: 24RS0A988O)  
    POTASSIUM BICARBONATE (UNII: HM5Z15LEBN)  
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37205-362-38296 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product06/21/1989
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33406/21/1989
    Labeler - Cardinal Health (097537435)
    Registrant - Vi-Jon, Inc (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, Inc790752542manufacture(37205-362)