Label: CITROMA- magesium citrate liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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 May 5, 2022

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  • TEP

    Do not use if tamper evident twist-off cap is missing, broken or separated from neckring

  • Active Ingredient

    Magnesium citrate 1.745g per fl oz

  • Purpose

    Saline laxative

  • use

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

    for this product

  • Ask A Doctor

    before use if you have

    • kidney disease
    • a magnesium or sodium 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 help professional before use.

  • Keep out of reach of children.

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

    Store at temperatures betweem 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 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

    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?

    Call 1-888-287-1915

  • Adverse Reaction

    Satisfaction guaranteed - For questions or comments please call 1-888-287-1915

    DISTRIBUTED BY: Walmart Inc.,

    Bentonville, AR 72716

  • principal display panel

    NDC

    equate

    Magnesium

    Citrate

    Saline

    Laxative

    • Relief of occasional constipation
    • For use in bowel cleansing systems for surgery or exam preparation
    • Non-pasteurized

    Lemon Flavor

    Empty & Replace Cap

    PLASTIC

    BOTTLE

    Alcohol content 0.0125% (from flavoring)

    10 FL OZ (296 mL)

    image description

  • INGREDIENTS AND APPEARANCE
    CITROMA 
    magesium citrate liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49035-506
    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)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49035-506-38296 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/29/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33404/29/2019
    Labeler - Walmart, Inc., (051957769)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(49035-506)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC088520668manufacture(49035-506)
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