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 August 21, 2019

If you are a consumer or patient please visit this version.

  • 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 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

  • Adverse Reaction

    Distributed by: Vi-Jon, Inc.

    One Swan Drive,

    Smyrna, TN 37167

    164.000/164AA

  • princpal display panel

    SWAN

    VERY LOW SODIUM

    Citroma

    MAGNESIUM CITRATE

    cherry

    • Saline Laxative
    • Oral Solution
    • Saccharin free

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

    10 FL OZ (296 mL)

    image description

  • INGREDIENTS AND APPEARANCE
    CITROMA 
    magnesium citrate liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0869-0164
    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:0869-0164-38296 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/18/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33402/18/2018
    Labeler - Vi-Jon, Inc (790752542)
    Registrant - Vi-Jon, Inc (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, Inc790752542manufacture(0869-0164)