MAGNESIUM CITRATE LIQUID [NUCARE PHARMACEUTICALS,INC.]

MAGNESIUM CITRATE LIQUID [NUCARE PHARMACEUTICALS,INC.]
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NDC 68071-4060-1
Set ID 570ac9c9-f139-336d-e054-00144ff88e88
Category HUMAN OTC DRUG LABEL
Packager NuCare Pharmaceuticals,Inc.
Generic Name
Product Class
Product Number
Application Number PART334
  • Active ingredients

    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

    Warnings for use of product

  • Do not use if 

    you are on a low salt diet

  • 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 two weeks
    • already used a laxative for a period longer than 1 week
  • Ask a doctor or pharmacist if

    you are taking any other drug.  Take this prouct 2 or more hours before or after other durgs.  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 help professional before use.

  • Keep out of reach of children

    In case of overdose, get medical help or contact a Poison Control Center right away

  • 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 in 24 hours
    • children 6 to under 12 years of age - 3 to 7 fl oz maximum 7 fl oz in 25 hours 
    • children 2 to 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

    •magnesium content 290 mg per 1 fl oz (30 mL)
    •sodium content 45 mg per 1 fl oz (30 mL)
    •store at temperaturs between 46⁰ and 86⁰ F (8⁰ and 30⁰ C)

  • inactive ingredients

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

  • Adverse reaction

    Distributed By McKesson

    One Post Street, San Francisco, CA 94104

    Money Back Guarantee

  • Principal display panel

    pdp

  • INGREDIENTS AND APPEARANCE
    MAGNESIUM CITRATE 
    magnesium citrate liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68071-4060(NDC:49348-696)
    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, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    SACCHARIN (UNII: FST467XS7D)  
    SUCROSE (UNII: C151H8M554)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68071-4060-1300 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product08/18/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33403/20/2012
    Labeler - NuCare Pharmaceuticals,Inc. (010632300)
    Establishment
    NameAddressID/FEIBusiness Operations
    NuCare Pharmaceuticals,Inc.010632300relabel(68071-4060)

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