MAGNESIUM CITRATE LIQUID [CARDINAL HEALTH]

MAGNESIUM CITRATE LIQUID [CARDINAL HEALTH]
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NDC 37205-110-38
Set ID 1df72d29-612d-4767-b8fc-ba2efc1665d1
Category HUMAN OTC DRUG LABEL
Packager Cardinal Health
Generic Name
Product Class
Product Number
Application Number PART334
  • 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