Label: MAGNESIUM CITRATE SALINE LAXATIVE- magnesium citrate liquid

  • NDC Code(s): 36800-626-10
  • Packager: TOP CARE (Topco Associates LLC)
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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 December 19, 2022

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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 Product07/31/201507/31/2025
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33407/31/201507/31/2025
    Labeler - TOP CARE (Topco Associates LLC) (006935977)
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