Label: ZICAM COLD REMEDY- zinc acetate and zinc gluconate bar, chewable

  • NDC Code(s): 62750-025-10
  • Packager: Matrixx Initiatives, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

Drug Label Information

Updated 12/10

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • ACTIVE INGREDIENT

    Active ingredients Purpose
    Zincum Aceticum 2x Reduces duration and severity
    Zincum Gluconicum 2x of a cold
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  • Uses

    • reduces duration of a cold
    • reduces severity of cold symptoms:
      • sore throat
      • stuffy nose
      • sneezing
      • coughing
      • congestion
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  • Warnings

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

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

    If pregnant or breast-feeding, ask a health professional before use.

    Keep out of reach of children.

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  • Directions

    • For best results, use at the first sign of a cold and continue to use for an additional 48 hours after symptoms subside.
    • Adults and children 12 years of age and older:
      • Take 1 chewable square at the onset of symptoms. Chew thoroughly before swallowing.
      • 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.
    • This product is not recommended for children under 12 years of age due to the hazard of choking.
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  • Inactive ingredients

    coconut oil, corn syrup, corn syrup solids, FD&C red No. 40, glycerin, natural and artificial flavors, purified water, soy lecithin, sucralose, sucrose, sugar

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  • Questions? Comments? Side Effects?

    call 877-942-2626 toll free or visit us on the web at www.zicam.com

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  • PRINCIPAL DISPLAY PANEL - 25 Chewable Carton

    NDC 62750-025-10

    ZICAM®

    Cold
    Remedy

    Get over your cold faster®

    Reduces the duration of a cold

    Chewables

    strawberry
    flavor

    25 Chewables
    Homeopathic

    Principal Display Panel - 25 Chewable Carton
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  • INGREDIENTS AND APPEARANCE
    ZICAM  COLD REMEDY
    zinc acetate and zinc gluconate bar, chewable
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:62750-025
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    zinc acetate (UNII: FM5526K07A) (zinc - UNII:J41CSQ7QDS) zinc acetate 2 [hp_X]
    zinc gluconate (UNII: U6WSN5SQ1Z) (zinc - UNII:J41CSQ7QDS) zinc gluconate 2 [hp_X]
    Inactive Ingredients
    Ingredient Name Strength
    coconut oil (UNII: Q9L0O73W7L)  
    corn syrup (UNII: 9G5L16BK6N)  
    FD&C red No. 40 (UNII: WZB9127XOA)  
    glycerin (UNII: PDC6A3C0OX)  
    water (UNII: 059QF0KO0R)  
    lecithin, soybean (UNII: 1DI56QDM62)  
    sucralose (UNII: 96K6UQ3ZD4)  
    sucrose (UNII: C151H8M554)  
    Product Characteristics
    Color RED Score no score
    Shape RECTANGLE Size 23mm
    Flavor STRAWBERRY Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:62750-025-10 1 in 1 CARTON
    1 25 in 1 BAG
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    Unapproved homeopathic 08/22/2003
    Labeler - Matrixx Initiatives, Inc. (790037253)
    Establishment
    Name Address ID/FEI Business Operations
    Best Sweet 002149136 MANUFACTURE
    Establishment
    Name Address ID/FEI Business Operations
    Boston Analytical 147830830 ANALYSIS
    Establishment
    Name Address ID/FEI Business Operations
    TLC Labs, Inc. 169896730 ANALYSIS
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