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 February 20, 2017

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

  • Active ingredient

    Magnesium citrate 1.745g per fl oz

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  • 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

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  • Do not use

    if you are on a low salt diet

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  • Ask A Doctor before use if you have

    • kidney disease
    • a magnesium or sodium restricted diet
    • abdorominal pain, nausea, or vomiting
    • noticed a sudden change in bowel habits tat persists over a period of 2 weeks
    • already used a laxative for a period longer than 1 week
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  • 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.

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  • Stop use

    and ask a doctor if you have rectal bleeding or failure to have a bowel movement afte use. These could be signs of a serious condition.

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  • if pregnant or breast-feeding

    ask help professional before use.

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  • Keep out of reach of children.

    In case of overdose, get medical help or contact a Poison Control Center right away

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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 maximum 7 fl oz in 24 hours

    children 2 to under 6 years of age - 2 to 3 fl oz maximum 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

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

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

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  • Questions

    Questions or Comments? 1-800-616-2471

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  • Adverse Reaction

    Distributed By: MAJOR PHARMACEUTICALS

    17177 N Laurel Park Drive, Suite 233

    Livonia, MI 014432

    667.001/667AG

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  • Principal display panel

    NDC 0904-6304-77

    MAJOR

    Magnesium Citrate

    Oral Solution

    Effervescent saline laxative

    Lemon flavored

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

    10 FL OZ (296 mL)

    image description

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  • INGREDIENTS AND APPEARANCE
    CITROMA 
    magesium citrate liquid
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0904-6304
    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)  
    POTASSIUM BICARBONATE (UNII: HM5Z15LEBN)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0904-6304-77 296 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 08/27/2012
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part334 08/27/2012
    Labeler - Major Pharmaceuticals (191427277)
    Registrant - Vi-Jon (790752542)
    Establishment
    Name Address ID/FEI Business Operations
    Vi-Jon 790752542 manufacture(0904-6304)
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