Label: MAGNESIUM CITRATE liquid

  • NDC Code(s): 36800-329-10
  • Packager: TOP CARE (Topco Associates LLC)
  • Category: HUMAN OTC DRUG LABEL

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 October 15, 2019

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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)