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

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 Item Code (Source) NDC:62750-057
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ZINC GLUCONATE (UNII: U6WSN5SQ1Z) (ZINC CATION - UNII:13S1S8SF37) ZINC GLUCONATE 1 [hp_X]
    Inactive Ingredients
    Ingredient Name Strength
    CROSPOVIDONE (UNII: 68401960MK)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MANNITOL (UNII: 3OWL53L36A)  
    MENTHOL (UNII: L7T10EIP3A)  
    AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    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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