MAGNESIUM CITRATE LIQUID [CARE ONE (AMERICAN SALES COMPANY)]

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MAGNESIUM CITRATE LIQUID [CARE ONE (AMERICAN SALES COMPANY)]
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NDC 41520-329-10
Set ID e7ca3d84-83f2-4140-a9e4-c07c6a7ebf6d
Category HUMAN OTC DRUG LABEL
Packager Care One (American Sales Company)
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 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

     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 11 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

    • each fluid ounce contains: magnesium 282 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 1-877-753-3935 Monday-Friday 9AM-5PM EST

  • Principal Display Panel

    MAGNESIUM CITRATE

    Oral Solution

    Effervescent Saline Laxative

    Lemon Flavored

    FL OZ (mL)

    TAMPER EVIDENT: DO NOT USE IF THE BREAKAWAY BAND ON CAP IS BROKEN OR MISSING.

    DISTRIBUTED BY FOODHOLD U.S.A. LLC, LANDOVER, MD 20785

    1-877-846-9949

  • Package Label

    Magnesium Citrate 1.745g per fl. oz

    CareOne Magnesium Citrate Lemon Flavored

  • INGREDIENTS AND APPEARANCE
    MAGNESIUM CITRATE 
    magnesium citrate liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-329
    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:41520-329-10296 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/31/201512/29/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33405/31/201512/29/2023
    Labeler - Care One (American Sales Company) (809183973)
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