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 December 4, 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 products

  • Ask a doctor before use if you have

    • kidney disease
    • a magnesium or sodium-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

  • 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 of 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

    • magnesium content 290 mg per 1 fl oz (30 mL)
    • potassum content 80 mg per 1 fl oz (30 mL)
    • store at temperatures between 46º and 86º F (8º and 30º C)
  • Inactive ingredients

    cherry flavor, citric acid, potassium bicarbonate, purified water, red 40, sodium saccharin

  • adverse reactions

    DISTRIBUTED BY:

    Vi-Jon

    One Swan Drive

    Smyrna, TN 37167

    Made in the USS

    with US and foreign parts

    693.001/693AD

  • principal display panel

    NDC 0869-0693-38

    swan

    VERY LOW SODIUM

    Citroma

    MAGNESIUM CITRATE

    cherry

    • Saline Laxative
    • Oral Solution
    • Alcohol Content 0.0031% (from flavoring)

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

    10 FL OZ (296 mL)

    image description

  • principal display panel

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

    mountain

    falls

    low sodium

    cherry

    flavor

    magnesium

    citrate

    saline laxative

    oral solution

    Alcohol content 0.0031% ( 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:0869-0693
    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
    CHERRY (UNII: BUC5I9595W)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    POTASSIUM BICARBONATE (UNII: HM5Z15LEBN)  
    water (UNII: 059QF0KO0R)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0869-0693-38296 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product07/15/1989
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33407/15/1989
    Labeler - Vi-Jon (790752542)
    Registrant - Vi-Jon (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon790752542manufacture(0869-0693)