MAGNESIUM CITRATE LIQUID [TOP CARE (TOPCO ASSOCIATES LLC)]

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MAGNESIUM CITRATE LIQUID [TOP CARE (TOPCO ASSOCIATES LLC)]
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NDC 36800-329-10
Set ID a0e0d1f1-1fda-44ee-ab69-b5faf19290e2
Category HUMAN OTC DRUG LABEL
Packager TOP CARE (Topco Associates LLC)
Generic Name
Product Class
Product Number
Application Number PART334
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  • Active ingredient

    Magnesium citrate 1.745g per fl. oz.

  • Purpose

    Saline laxative

  • Uses

    • relieves occasional constipation (irregularity)
    • generally produces bowel movement in 1/2 to 6 hours
  • Warnings

    Do not use

     laxative products for longer than 1 week unless directed by a doctor.

    Ask a doctor before use if you have

    • kidney disease
    • a magnesium restricted diet
    • a sodium restricted diet
    • stomach pain, nausea, or vomiting
    • noticed a sudden change in bowel habits that last more than 1 week

    Ask a doctor or pharmacist before use if you are

    presently taking a prescription drug. 

    When using this product,

    do not exceed the maximum recommended daily dosage in a 24 hour period 

    Stop use and ask a doctor if

    you have rectal bleeding or no 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 (1-800-222-1222) right away.

  • Directions

    • drink a full glass (8 ounces) of liquid with each dose
    • may be taken as a single daily dose in divided doses
    adults and children 12 years of age and over1/2 bottle to 1 bottle (10 fl oz) 
    children 6 to 11 years of age 1/3 bottle to 1/2 bottle 
    children under 6 years of age consult a doctor 

  • Other information

    • each fluid ounce contains: magnesium 280 mg, sodium 37 mg
    • store between 46-86ºF(8-30ºC) Do not refrigerate.
    • protect from excessive heat and freezing
    • discard unused product within 24 hours of opening bottle
  • Inactive ingredients

    citric acid, flavors, purified water, saccharin sodium, sodium bicarbonate

  • Questions or comments?

    Call toll free 1-888-423-0139

  • Principal Display Panel

    Magnesium Citrate

    SALINE LAXATIVE

    ORAL SOLUTION

    For Relief of Occasional Constipation

    FL OZ (mL)

    LEMON FLAVOR

    TAMPER EVIDENT: DO NOT USE IF THE BREAKAWAY BAND ON CAP IS BROKEN OR MISSING.

    DISTRIBUTED BY TOPCO ASSOCIATES LLC

    ELK GROVE VILLAGE, IL 60007

    topcare@topco.com

    www.topcarebrand.com

  • Package Label

    Magnesium Citrate 1.745g

    TOPCARE HEALTH Magnesium Citrate Lemon Flavor

  • INGREDIENTS AND APPEARANCE
    MAGNESIUM CITRATE 
    magnesium citrate liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-329
    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
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM ANHYDROUS (UNII: I4807BK602)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorLEMONImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:36800-329-10296 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product07/31/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart33407/31/2015
    Labeler - TOP CARE (Topco Associates LLC) (006935977)
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