Label: MAGNESIUM CITRATE- freskaro magnesium citrate oral solution - grape liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 22, 2023

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  • Active Ingredient

    Magnesium citrate 1.745g per fl oz

  • Purpose

    Saline Laxtive

  • Use

    for relief of occasional constipation (irregularity).
    Generally produces bowel movement in 1/2 to 6 hours

  • Warnings

    kidney disease
    a magnesium restricted diet
    abdorominal pain, nausea, or vomiting
    noticed a sudden change in bowel habits that persists over a period of 2 weeks
    already used a laxative for a period longer than 1 week

  • ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE

    taking any other drug.
    Take this product 2 or more hours before or after other drugs. Laxatives may affect how other drugs work.

  • STOP USE AND ASK A DOCTOR IF

    you have rectal bleeding or failure to have a bowel movement after use. These could be signs of a serious condition.

  • IF PREGNANT OR BREAST-FEEDING

    ask health professional before use.

  • KEEP OUT OF REACH OF CHILDREN.

    In case of overdose, get medical help or contact a Poison Control Center right away.

  • Other Information

    Store at temperatures between 46° and 86°F (8° and 30° C)

  • Directions

    shake well before using
    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 over - 6.5 to 10 fl oz maximum 10 fl oz in 24 hours

    children 6 to under 12 years of age - 3 to 7 fl oz maximum 7 fl oz in 24 hours

    children 2 to under 6 years of age - 2 to 3 fl oz in 24 hours maximum 3 fl oz in 24 hours

    children under 2 years of age - ask a doctor

  • Other Information

    each fl oz contains: magnesium 290 mg
    each fl oz contains: sodium 1 mg

  • Inactive Ingredients

    benzoic acid, citric acid, disodium EDTA, flavor, sucralose, water

  • Questions?

    1-833-551-0932

  • PRINCIPAL DISPLAY PANEL

    Freskaro Magnesium Citrate Grape Version 1

  • INGREDIENTS AND APPEARANCE
    MAGNESIUM CITRATE 
    freskaro magnesium citrate oral solution - grape liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82645-311
    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
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    WATER (UNII: 059QF0KO0R)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82645-311-10296 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/27/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00712/27/2022
    Labeler - Pharma Nobis, LLC (118564114)
    Registrant - Pharma Nobis, LLC (118856114)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharma Nobis, LLC118564114label(82645-311) , manufacture(82645-311) , analysis(82645-311) , pack(82645-311)
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