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 November 14, 2014

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

  • Active Ingredient

    Magnesium citrate 1.745 g per fl oz

  • Purpose

    Saline Laxative

  • Use

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

  • Warnings

    Do not use

    • if you are on a low salt diet
  • 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 use a laxative for a period longer than 1 week
  • Ask a doctor or pharmacist before use if you are

     taking any other drugs. 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 moverment 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

    Other information

    • magnesium content 290 mg per 1 fl oz (30 mL)
    • sodium content 45 mg per 1 fl oz (30 mL)
    • store at temperatures between 46º and 86º F (8º and 30º C)
  • Inactive ingredients

     citric acid, lemon oil, polyethylene glycol, purified water, sodium bicarbonate, sodium saccharin, sucrose

  • Questions or comments

    1-800-525-2558

  • Adverse Reactions

    Proudly Distribted by Western Family Foods, Inc.

    P.O.Box 4057, Portland, OR 97208 U.S.A.

    Copyright 2014 Marca Registrada

    www. westernfamily.com

  • Principal Display Panel

    WESTERN

    FAMILY

    Magnesium

    Citrate

    Saline Laxatixe

    Oral Solution

    TAMPER  EVIDENT:

    DO NOT USE IF THE BREAKAWAY BAND ON CAP IS BROKEN OR MISSING.

    10 FL OZ (296 mL)

    image description

  • INGREDIENTS AND APPEARANCE
    CITROMA 
    magnesium citrate liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55312-667
    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)  
    LEMON OIL (UNII: I9GRO824LL)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SUCROSE (UNII: C151H8M554)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55312-667-38296 mL in 1 BOTTLE, GLASS
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33404/15/1990
    Labeler - Western Family Foods, Inc (192166072)
    Registrant - Vi-Jon (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon790752542manufacture(55312-667)