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 April 22, 2019

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 sodium-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 a 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.

    storage information

    store at temperatures between 46⁰ and 86⁰ F (8⁰ and 30⁰ 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 fl oz maximum 3 fl oz in 24 hours

    children under 2 years of age- ask a doctor

    discard unused product within 24 hours of opening bottle

  • Other information

    • each fl oz contains: magnesium content 290 mg
    • each fl oz contains: sodium 45 mg
  • Inactive ingredients

    citric acid, lemon oil, polyethylene glycol, purified water, sodium bicarbonate, sodium saccharin, sucrose

  • Questions?

    Call 1-888-593-0593

  • Disclaimer

    CARDINAL HEALTH, the Cardinal Health LOGO, LEADER,  and the Leader LOGO are tradmarked or registered trademark of Cardinal Health

  • Adverse reaction

    DISTRIBUTED BY

    CARDINAL  HEALTH

    DUBLIN, OHIO, 43017

    www.myleader.com

    1-800-200-6313

    Essential to Care since 1979

    100% Money Back Guarantee

    Return to place of purchase

    CardinalHealth

    CIN 5385141

    REV. 9/17

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

    667.001/667AG

  • princial display panel

    LEADER

    NDC 70000-0318-1

    MAGNESIUM

    CITRATE

    SALINE LAXATIVE

    LEMON FLAVOR

    ORALSOLUTION

    PASTEURIZED SPARKLING

    LAXATIVE

    DYE-FREE

    100% MONEY BACK GUARANTEE

    10 FL OZ (296 mL)

    image description

  • INGREDIENTS AND APPEARANCE
    MAGNESIUM CITRATE 
    magnesium citrate liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0318
    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 OIL (UNII: I9GRO824LL)  
    POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)  
    water (UNII: 059QF0KO0R)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SUCROSE (UNII: C151H8M554)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorLEMONImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70000-0318-1.296 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(70000-0318)