Label: MAGNESIUM CITRATE liquid

  • Category: HUMAN OTC DRUG LABEL

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 16, 2019

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  • Active ingredient (in each fl oz)

    Magnesium citrate 1.745g

  • 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

    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 each dose
    • may be taken as a single daily dose or in divided doses
    adults and children 12 years of age and over1/2 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, saccharin sodium, sodium bicarbonate

  • Questions or comments?

    Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

  • Principal Display Panel

    Magnesium Citrate

    Saline Laxative

    Oral Solution

    Dye-Free

    Sugar-Free

    GRAPE FLAVOR

    FL OZ (mL)

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

    DISTRIBUTED BY: fred's, Inc.

    4300 NEW GETWELL RD, MEMPHIS, TN 38118

    www.fredsinc.com

  • Package Label

    Magnesium Citrate 1.745g

    FRED'S PHARMACY Magnesium Citrate Dye-Free Grape Flavor

  • INGREDIENTS AND APPEARANCE
    MAGNESIUM CITRATE 
    magnesium citrate liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55315-327
    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
    FlavorGRAPEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55315-327-10296 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product07/31/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart33407/31/2018
    Labeler - Freds Inc (005866116)