ZICAM COLD REMEDY ORAL MIST (ZINC ACETATE AND ZINC GLUCONATE) SPRAY [MATRIXX INITIATIVES, INC.]

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ZICAM COLD REMEDY ORAL MIST (ZINC ACETATE AND ZINC GLUCONATE) SPRAY [MATRIXX INITIATIVES, INC.]
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NDC 62750-060-10
Set ID ea926827-cfea-4a5d-842e-057165de2216
Category HUMAN OTC DRUG LABEL
Packager Matrixx Initiatives, Inc.
Generic Name
Product Class
Product Number
Application Number
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients

    Zincum aceticum 2x
    Zincum gluconicum 1x

  • Purpose

    Reduces duration and severity of the common cold

  • Uses

    • reduces duration of the common cold
    • helps reduce 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.

  • Warnings

    For oral use only

    Sore throat warning

    If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

    Ask a doctor before use if you have a sensitivity to zinc or are allergic to zinc

    When using this product avoid contact with eyes. Rinse right away with water if it gets in eyes and seek medical help right away.

    Stop use and ask a doctor if symptoms, including cough, persist, recur or are accompanied by a fever, rash, or persistent headache, or if new symptoms occur. A persistent cough that lasts for more than one week may be a sign 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

    • 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:
      • spray 4 times in mouth at the onset of symptoms. Spray on inside of cheeks, roof of mouth and gums. Retain for 15 seconds. Swallow.
      • repeat every 2- 3 hours, not to exceed 7 doses in 24 hours. Take 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
  • Other information

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

    benzalkonium chloride, glycerin, menthol, natural & artificial flavor, PEG-40 hydrogenated castor oil, purified water, sucralose, xylitol

  • Questions? Comments? Side Effects?

    call 877-942-2626 toll free

  • SPL UNCLASSIFIED SECTION

    Distributed by Matrixx Initiatives, Inc.
    Scottsdale, Arizona 85260.

  • PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton

    NDC 62750-060-10

    ZICAM®
    COLD REMEDY

    SHORTENS COLDS

    + SOOTHES SORE THROATS
    AND COUGHS

    TAKE AT THE FIRST
    SIGN OF A COLD

    THE
    PRE-COLD®
    MEDICINE

    SEE
    WHAT'S
    INSIDE!

    CLINICALLY PROVEN TO SHORTEN COLDS

    ORAL MIST™

    GREAT TASTING

    Arctic Mint Flavor

    1.0 FL OZ
    (30 mL)

    HOMEOPATHIC

    PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton
  • INGREDIENTS AND APPEARANCE
    ZICAM COLD REMEDY ORAL MIST 
    zinc acetate and zinc gluconate spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62750-060
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC ACETATE (UNII: FM5526K07A) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION2 [hp_X]  in 1 mL
    ZINC GLUCONATE (UNII: U6WSN5SQ1Z) (ZINC CATION - UNII:13S1S8SF37) ZINC GLUCONATE1 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    WATER (UNII: 059QF0KO0R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    XYLITOL (UNII: VCQ006KQ1E)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62750-060-101 in 1 CARTON03/01/2013
    130 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED HOMEOPATHIC03/01/2013
    Labeler - Matrixx Initiatives, Inc. (790037253)
    Establishment
    NameAddressID/FEIBusiness Operations
    Accupac, Inc071609663MANUFACTURE(62750-060)
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