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

  • Label RSS
  • NDC Code(s): 62750-025-10
  • 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 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 LABEL Item Code (Source) NDC:62750-025
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    zinc acetate (zinc) zinc acetate 2 [hp_X]
    zinc gluconate (zinc) zinc gluconate 2 [hp_X]
    Inactive Ingredients
    Ingredient Name Strength
    coconut oil  
    corn syrup  
    FD&C red No. 40  
    glycerin  
    water  
    lecithin, soybean  
    sucralose  
    sucrose  
    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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