MAGNESIUM CITRATE LIQUID [FREDS INC]

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MAGNESIUM CITRATE LIQUID [FREDS INC]
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NDC 55315-327-10
Set ID be58b829-8e72-4057-8762-6b40c7616214
Category HUMAN OTC DRUG LABEL
Packager Freds Inc
Generic Name
Product Class
Product Number
Application Number PART334
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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)
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