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

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MAGNESIUM CITRATE SALINE LAXATIVE (MAGNESIUM CITRATE) LIQUID [TOP CARE (TOPCO ASSOCIATES LLC)]
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NDC 36800-626-10
Set ID 29091600-a3ca-4346-bdeb-651131b90e2f
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 lasts 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 beach dose
    • may be taken as a single daily dose or in divided doses
    adults and children 12 years of age1/2 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, FD&C red 40, 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

    CHERRY FLAVOR

    FL OZ (mL)

    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 © TOPCO

    topcare@topco.com

    www.topcarebrand.com

  • Package Label

    Magnesium Citrate 1.745g

    TOPCARE HEALTH Magnesium Citrate

  • INGREDIENTS AND APPEARANCE
    MAGNESIUM CITRATE  SALINE LAXATIVE
    magnesium citrate liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-626
    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)  
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:36800-626-10296 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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