Label: MAGNESIUM CITRATE liquid

  • 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 April 28, 2011

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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

    ask a doctor before use if you have:

    kidney disease

    a magnesium restricted diet

    stomach pain,  nausea or vomiting

    noticed a sudden change in bowel habits that lasts more than one 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 a sign of a serious condition.

    you need to use a laxative more than one week.

  • If pregnant or breast feeding

    ask a health professional before use.

  • keep this and all drugs out of the reach of children.

    In case of accidental overdose, seek professional assistance or contact a poison control center immediately.

  • Directions

    Adults and Children 12 years of age and older             1/2 to 1 bottle (10 fl oz). Drink a full 8 oz glass of liquid with each dose.                                                                                 The dose may be taken as a single daily dose or in divided doses.

    children 6 to under 12 years of age                               1/3 to 1/2 bottle with a full 8 oz glass of liquid.

    children under 6 years of age                                        consult a doctor


  • Other Information

    store at controlled room temperature

    protect from excessive heat and freezing

    discard unused product within 24 hours of opening bottle


  • Inactive Ingredients

    Citric acid, flavors, potassium bicarbonate, saccharin sodium, purified water

  • Questions or Comments?

    1-866-534-4631

  • Principal Display Panel

    Magnesium Citrate

  • INGREDIENTS AND APPEARANCE
    MAGNESIUM CITRATE 
    magnesium citrate liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21695-934(NDC:0904-0304)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MAGNESIUM CITRATE (UNII: RHO26O1T9V) (Magnesium Cation - UNII:T6V3LHY838) MAGNESIUM CITRATE2.62 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SACCHARIN SODIUM ANHYDROUS (UNII: I4807BK602)  
    POTASSIUM BICARBONATE (UNII: HM5Z15LEBN)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorLEMON (Lemon) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:21695-934-10296 mL in 1 BOTTLE, GLASS
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33407/31/2009
    Labeler - Rebel Distributors Corp (118802834)
    Establishment
    NameAddressID/FEIBusiness Operations
    Rebel Distributors Corp118802834RELABEL, REPACK
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