Label: ZICAM- zinc acetate and zinc gluconate tablet, orally disintegrating

  • NDC Code(s): 62750-035-10, 62750-035-11
  • 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 1x 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:
      • Dissolve entire tablet in mouth. Do not chew. Do not swallow whole.
      • Take 1 tablet at the onset of symptoms.
      • 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: Consult a doctor before use.
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  • Inactive ingredients

    ascorbic acid, crospovidone, echinacea purpurea, FD&C Lake Yellow No. 5 (tartrazine), magnesium stearate, mannitol, mono-ammonium glycyrrhizinate, natural flavor, sodium starch glycolate, stearic acid, sucralose

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  • STORAGE AND HANDLING

    Store at room temperature 15°C-29°C (59°F-84°F)

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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 Tablet Carton

    NDC 62750-035-10

    ZICAM®

    Cold
    Remedy

    Get rid of your cold faster

    ✔ Reduces the duration of a cold

    Melts in
    Your Mouth

    RapidMelts®
    with Vitamin C
    & Echinacea

    lemon-lime
    flavor

    25 Quick Dissolve Tablets

    Homeopathic

    Principal Display Panel - 25 Tablet Carton
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  • INGREDIENTS AND APPEARANCE
    ZICAM 
    zinc acetate and zinc gluconate tablet, orally disintegrating
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:62750-035
    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 1 [hp_X]
    Inactive Ingredients
    Ingredient Name Strength
    ascorbic acid (UNII: PQ6CK8PD0R)  
    crospovidone (UNII: 68401960MK)  
    echinacea purpurea (UNII: QI7G114Y98)  
    FD&C Yellow No. 5 (UNII: I753WB2F1M)  
    aluminum oxide (UNII: LMI26O6933)  
    magnesium stearate (UNII: 70097M6I30)  
    mannitol (UNII: 3OWL53L36A)  
    glycyrrhizin, ammoniated (UNII: 3VRD35U26C)  
    stearic acid (UNII: 4ELV7Z65AP)  
    sucralose (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    Color YELLOW Score no score
    Shape ROUND Size 15mm
    Flavor LEMON Imprint Code Z
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:62750-035-10 1 in 1 CARTON
    1 25 in 1 BOTTLE, PLASTIC
    2 NDC:62750-035-11 1 in 1 CARTON
    2 45 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    Unapproved homeopathic 11/07/2008
    Labeler - Matrixx Initiatives, Inc. (790037253)
    Establishment
    Name Address ID/FEI Business Operations
    Nutritional Labs International 007306970 Manufacture
    Establishment
    Name Address ID/FEI Business Operations
    TLC Labs, Inc 169896730 Analysis
    Establishment
    Name Address ID/FEI Business Operations
    Boston Analytical, Inc. 147830830 Analysis
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