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 November 29, 2011

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  • ACTIVE INGREDIENT

    Active ingredient
    Magnesium citrate 1.745 g per fl oz

    Purpose
    Saline Laxative
  • INDICATIONS & USAGE

    Use for relief of occasional constipation (irregularity). Generally produces bowel movement in 1/2 to 6 hours
  • WARNINGS

    Warnings

    Ask a doctor before use if you have
    •kidney disease
    •a magnesium or potassium-restricted diet
    •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
    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.
  • DOSAGE & ADMINISTRATION

    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 SAFETY INFORMATION

    Other information • magnesium content 290 mg per 1 fl oz (30 mL)
    •potassium content 80 mg per 1 fl oz (30mL)
    •store at temperatures between 46⁰ and 86⁰ F (8⁰ and 30⁰ C)
  • INACTIVE INGREDIENT

    Inactive ingredients citric acid, lemon oil, potassium bicarbonate,
    sodium saccharin, water purified
  • PRINCIPAL DISPLAY PANEL

    DO NOT USE IF TAMPER EVIDENT TWIST OFF-OFF CAP IS MISSING,
    BROKEN OR SEPARATED FROM NECKRING
    NDC37205-110-38
    LEADER
    Magnesium
    Citrate
    Oral Solution
    Saline Laxative
    Lemon flavor
    Pasteurized
    The Sparkling Laxative
    10 FL OZ (296 mL)
    image of principal display package
  • INGREDIENTS AND APPEARANCE
    MAGNESIUM CITRATE 
    magnesium citrate liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37205-110
    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
    LEMON OIL (UNII: I9GRO824LL)  
    POTASSIUM BICARBONATE (UNII: HM5Z15LEBN)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorLEMON (LEMON FLAVOR) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37205-110-38.296 mL in 1 BOTTLE, GLASS
    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
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