Label: ZICAM COLD REMEDY RAPIDMELTS- zinc gluconate tablet 

  • NDC Code(s): 62750-057-10
  • Packager: Matrixx Initiatives, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 02/13

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active ingredient (in each tablet)

    Zincum gluconicum 1x

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  • Purpose

    Reduces duration and severity of the common cold

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  • Uses

    • reduces duration of the common cold
    • reduces severity of cold symptoms:
      • sore throat
      • stuffy nose
      • sneezing
      • coughing
      • nasal congestion

    Zicam® Cold Remedy was formulated to shorten the duration of the common cold and was not formulated to be effective for flu or allergies.

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  • Warnings

    Ask a doctor before use if you have

    • a sensitivity to zinc or are allergic to zinc

    Stop use and ask a doctor if symptoms persist or are accompanied by fever

    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.

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  • Directions

    • for best results, use at the first sign of a cold and continue to use until symptoms completely subside
    • adults and children 12 years of age and older:
      • take 1 tablet at the onset of symptoms
      • dissolve entire tablet in mouth. Do not chew. Do not swallow whole.
      • repeat every 3 hours until symptoms are gone
      • to avoid minor stomach upset, do not take on an empty stomach
      • do not eat or drink for 15 minutes after use. Do not eat or drink citrus fruits or juices for 30 minutes before or after use. Otherwise, drink plenty of fluids.
    • children under 12 years of age: ask a doctor before use
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  • Other information

    • store between 15-29°C (59-84°F)
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  • Inactive ingredients

    crospovidone, FD&C blue no. 2 aluminum lake, magnesium stearate, mannitol, menthol, mono-ammonium glycyrrhizinate, natural and artificial flavors, sodium starch glycolate, stearic acid, sucralose

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  • QUESTIONS

    Questions? Comments?
    Side Effects?
    call 877-942-2626 toll free
    or visit us on the web at
    www.zicam.com

    Distributed by Matrixx Initiatives, Inc.
    Scottsdale, Arizona 85255.

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  • PRINCIPAL DISPLAY PANEL - 25 Tablet Bottle Carton

    NDC 62750-057-10

    ZICAM®
    COLD REMEDY

    Zincum gluconicum

    TAKE AT THE FIRST
    THE
    PRE-COLD™
    MEDICINE

    SIGN OF A COLD

    REDUCES THE DURATION OF A COLD

    RAPIDMELTS®

    Cool Mint Flavor

    25
    Quick Dissolve
    TABLETS

    HOMEOPATHIC

    Principal Display Panel - 25 Tablet Bottle Carton
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  • INGREDIENTS AND APPEARANCE
    ZICAM COLD REMEDY RAPIDMELTS 
    zinc gluconate tablet
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:62750-057
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ZINC GLUCONATE (ZINC CATION) ZINC GLUCONATE 1 [hp_X]
    Inactive Ingredients
    Ingredient Name Strength
    CROSPOVIDONE  
    FD&C BLUE NO. 2  
    ALUMINUM OXIDE  
    MAGNESIUM STEARATE  
    MANNITOL  
    MENTHOL  
    AMMONIUM GLYCYRRHIZATE  
    SODIUM STARCH GLYCOLATE TYPE A POTATO  
    STEARIC ACID  
    SUCRALOSE  
    Product Characteristics
    Color BLUE Score no score
    Shape ROUND Size 15mm
    Flavor MINT Imprint Code Z
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:62750-057-10 1 in 1 CARTON
    1 25 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    Unapproved homeopathic 02/01/2013
    Labeler - Matrixx Initiatives, Inc. (790037253)
    Establishment
    Name Address ID/FEI Business Operations
    Nutritional Labs International 007306970 MANUFACTURE(62750-057)
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