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 February 7, 2022

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  • ACTIVE INGREDIENT

    Active ingredient
    Magnesium citrate 1.745 g per fl oz

    Purpose
    Saline laxative

  • INDICATIONS & USAGE

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

  • WARNINGS

    Warnings

    Ask a doctor before use if you have
    •kidney disease
    •a magnesium or potassium-restricted diet
    •abdominal 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 a 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.

  • DOSAGE & ADMINISTRATION

    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 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 25 hours
    children 2 to 6 years of age - 2 to 3 fl oz maximum 3 fl oz in 24 hours
    children under 2 years of age- ask a doctor
    discard unused product within 24 hours of opening bottle

  • OTHER SAFETY INFORMATION

    Other information
    •magnesium content 290 mg per 1 fl oz (30 mL)
    •potassium content 80 mg per 1 fl oz (30 mL)
    •store at temperaturs between 46⁰ and 86⁰ F (8⁰ and 30⁰ C)

  • INACTIVE INGREDIENT

    Inactive ingredients cherry flavor, citric acid, FD+C red # 40, potassium bicarbonate, sodium saccharin, water purified

  • PRINCIPAL DISPLAY PANEL

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  • INGREDIENTS AND APPEARANCE
    MAGNESIUM CITRATE 
    magnesium citrate liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68071-4128(NDC:49348-504)
    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
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    POTASSIUM BICARBONATE (UNII: HM5Z15LEBN)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68071-4128-10.296 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product10/25/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33403/01/2002
    Labeler - NuCare Pharmaceuticals,Inc. (010632300)
    Establishment
    NameAddressID/FEIBusiness Operations
    NuCare Pharmaceuticals,Inc.010632300relabel(68071-4128)
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