MAGNESIUM CITRATE LIQUID [SUPERVALU, INC.]

MAGNESIUM CITRATE LIQUID [SUPERVALU, INC.]
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NDC 41163-380-38
Set ID f88131bd-5464-47d8-8c51-3128d879fe4e
Category HUMAN OTC DRUG LABEL
Packager UNFI
Generic Name
Product Class
Product Number
Application Number PART334
  • Active Ingredient (in each fl oz)

    Magnesium citrate 1.745 g

  • Purpose

    Saline laxative

  • 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-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.

  • 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 24 hours

    children 2 to under 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 information

    • each fl oz contains:  magnesium 290 mg 
    • each fl oz contains:  sodium content 3 mg
    • each fl oz contains:  potassium content 84 mg
    • store at temperatures between 46º and 86º F (8º and 30º C)
  • Inactive ingredients

     citric acid, flavor, potassium bicarbonate, sodium saccharin, water

  • SPL UNCLASSIFIED SECTION

    Distributed by: SUPERVALU, INC. Eden Prairie, MN 55344 USA

    Contact us at 1-877-932-7948

    or www.supervalu-ourownbrands.com

    Gluten free

  • principal display panel

    EQUALINE

    low sodium

    Magnesium Citrate

    Saline Laxative Oral Solution

    • sparkling
    • pasteurized

    Cherry Flavor

    Alcohol content 0.0031% (from flavoring)

    10 FL OZ (296 mL)

    DO NOT USE TAMPER EVIDENT TWIST-OFF CAP IS MISSING, BROKEN OR SEPARATED FROM NECKRING

    image description

  • INGREDIENTS AND APPEARANCE
    MAGNESIUM CITRATE 
    magnesium citrate liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41163-380
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MAGNESIUM CITRATE (UNII: RHO26O1T9V) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM CITRATE1.745 g  in 29.61 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    POTASSIUM BICARBONATE (UNII: HM5Z15LEBN)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41163-380-38296 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product09/23/2011
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33409/23/2011
    Labeler - UNFI (006961411)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(41163-380)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC088520668manufacture(41163-380)

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