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 7, 2018

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

  • Active ingredient

    Magnesium citrate

    Purpose

    Saline laxative

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  • Use

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

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  • Warnings

    for this product

    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 used a laxative for a period longer than 1 week

    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 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

    store at temperatures between 46⁰ and 86⁰F (8⁰ and 30⁰ C)

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  • 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 in 24 hours

    children 6 to under 12 years of age 3 to 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

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  • Other information

    • each fl oz contains: magnesium 290 mg
    • each fl oz contains: sodium 45 mg
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  • Inactive ingredients

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

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  • Adverse reactions section

    Distributed by:

    Vi-Jon

    One Swan Drive

    Smyrna, TN 37167

    667.001/667AG

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  • Principal Display panel

    NDC 0869-0667-38

    Swan

    Citroma

    MAGNESIUM CITRATE

    lemony

    • Oral Solution
    • Saline Laxative
    • Pasteurized
    • The Sparkling Laxative

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

    10 FL OZ (296 mL)

    image of principal display panel

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  • INGREDIENTS AND APPEARANCE
    CITROMA 
    magnesium citrate liquid
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0869-0667
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MAGNESIUM CITRATE (UNII: RHO26O1T9V) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM CITRATE 1.745 g  in 29.6 mL
    Inactive Ingredients
    Ingredient Name Strength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    LEMON OIL (UNII: I9GRO824LL)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    water (UNII: 059QF0KO0R)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SUCROSE (UNII: C151H8M554)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0869-0667-38 296 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 07/15/1989
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part334 07/15/1989
    Labeler - Vi Jon, Inc (790752542)
    Registrant - Vi Jon, Inc (790752542)
    Establishment
    Name Address ID/FEI Business Operations
    Vi Jon Inc 790752542 manufacture(0869-0667)
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