Label: CITROMA- magnesium 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 March 31, 2023

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  • Active ingredient (in each fl oz)

    Magnesium citrate 1.745g

  • Purpose

    Saline laxative

  • Uses

    • 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 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 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

  • STORAGE AND HANDLING

    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 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

  • SPL UNCLASSIFIED SECTION

    Non-USP: Non-Carbonated, Non-Pasteurized; Contains Preservatives

    Since 1903 Rexall is a registered trademark of Rexall Sundown, Inc.

    Visit us at Rexall.com or call 1-866-4-REXALL

    DISTRIBUTED BY OLD EAST MAIN CO.

    100 MISSION RIDGE

    GOODLETTSVILLE, TN 37072

  • Principal display panel

    Since 1903

    Rexall

    Magnesium

    Citrate

    Saline Laxative

    • Oral solution
    • Relief of occasional constipation

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

    Grape

    Flavored

    10 FL OZ (296 mL)

    image description

  • INGREDIENTS AND APPEARANCE
    CITROMA 
    magnesium citrate liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55910-615
    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:55910-615-38296 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/04/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33409/04/2019
    Labeler - OLD EAST MAIN CO (068331990)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(55910-615)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC088520668manufacture(55910-615)
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