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

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

    Close
  • ACTIVE INGREDIENT

    Active ingredients Purpose
    Zincum Aceticum 2x Reduces duration and severity
    Zincum Gluconicum 1x of a cold
    Close
  • Uses

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

    Close
  • 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.
    Close
  • 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

    Close
  • STORAGE AND HANDLING

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

    Close
  • Questions? Comments? Side Effects?

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

    Close
  • 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
    Close
  • INGREDIENTS AND APPEARANCE
    ZICAM 
    zinc acetate and zinc gluconate tablet, orally disintegrating
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:62750-035
    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 1 [hp_X]
    Inactive Ingredients
    Ingredient Name Strength
    ascorbic acid  
    crospovidone  
    echinacea purpurea  
    FD&C Yellow No. 5  
    aluminum oxide  
    magnesium stearate  
    mannitol  
    glycyrrhizin, ammoniated  
    stearic acid  
    sucralose  
    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
    Close