Label: MAGNESIUM CITRATE - magnesium citrate liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 11/09

If you are a consumer or patient please visit this version.

  • Active ingredient

    Magnesium Citrate 1.745g per fl oz

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  • Purpose

    saline laxative

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  • Uses

    relieves occasional constipation (irregularity)

    generally produces bowel movement in 1/2 to 6 hours

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  • Warnings

    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 one week


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  • Ask a doctor or pharmacist before use if you are

    presently taking a prescription drug

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  • when using this product

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

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  • 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.

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  • If pregnant or breast feeding

    ask a health professional before use.

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  • 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.
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  • 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


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  • Other Information

    each fluid ounce contains: sodium 36 mg

    store at controlled room temperature

    protect from excessive heat and freezing

    discard unused product within 24 hours of opening bottle


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  • Inactive Ingredients

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

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  • Questions?

    Adverse Drug Events Call: (800) 616-2471

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  • Principal Display Panel

    Preferred Plus Pharmacy

    Pasteurized

    The Sparkling Laxative

    Magnesium

    Citrate

    Oral Solution

    (Citrate of Magnesia)

    Lemon Flavor

    TAMPER EVIDENT:  DO NOT USE IF THE BREAKAWAY

    BAND ON CAP IS BROKEN OR MISSING

    10 FL OZ (296 mL)

    image of label

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  • INGREDIENTS AND APPEARANCE
    MAGNESIUM CITRATE  
    magnesium citrate liquid
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:63777-314
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MAGNESIUM CITRATE (magnesium cation) MAGNESIUM CITRATE 2.65 mL  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    water  
    CITRIC ACID MONOHYDRATE  
    SACCHARIN SODIUM ANHYDROUS  
    SODIUM BICARBONATE  
    Product Characteristics
    Color      Score     
    Shape Size
    Flavor LEMON (Lemon) Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:63777-314-16 296 mL in 1 BOTTLE, GLASS
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part334 03/20/2009
    Labeler - Kinray Inc (012574513)
    Registrant - Aaron Industries, Inc. (030119387)
    Establishment
    Name Address ID/FEI Business Operations
    Aaron Industries, Inc. 030119387 analysis, manufacture
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