ZICAM COLD REMEDY RAPIDMELTS (ZINC ACETATE ANHYDROUS AND ZINC GLUCONATE) TABLET [MATRIXX INITIATIVES, INC.]

ZICAM COLD REMEDY RAPIDMELTS (ZINC ACETATE ANHYDROUS AND ZINC GLUCONATE) TABLET [MATRIXX INITIATIVES, INC.]
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NDC 62750-054-10
Set ID 4395b7e2-5459-49c8-af7c-74e76ac933de
Category HUMAN OTC DRUG LABEL
Packager Matrixx Initiatives, Inc.
Generic Name
Product Class
Product Number
Application Number
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients (in each tablet)

    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

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

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

    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:
      • take 1 tablet at the onset of symptoms
      • dissolve entire tablet in mouth. Do not chew. Do not swallow whole.
      • repeat every 2 – 3 hours, not to exceed 7 tablets 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

    artificial flavor, crospovidone, FD&C red no. 40 aluminum lake, magnesium stearate, mannitol, mono-ammonium glycyrrhizinate, sodium starch glycolate, stearic acid, sucralose

  • Questions? Comments? Side Effects?

    call 877-942-2626 toll free
    www.zicam.com

  • SPL UNCLASSIFIED SECTION

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

  • PRINCIPAL DISPLAY PANEL - 25 Tablet Bottle Carton

    NDC 62750-054-10

    ZICAM®
    COLD REMEDY

    SHORTENS COLDS

    TAKE AT THE FIRST
    SIGN OF A COLD

    THE
    PRE-COLD®
    MEDICINE

    CLINICALLY PROVEN TO SHORTEN COLDS

    GREAT
    TASTING!

    RAPIDMELTS®

    Cherry Flavor

    25
    Quick Dissolve
    TABLETS

    HOMEOPATHIC

    PRINCIPAL DISPLAY PANEL - 25 Tablet Bottle Carton
  • INGREDIENTS AND APPEARANCE
    ZICAM   COLD REMEDY RAPIDMELTS
    zinc acetate anhydrous and zinc gluconate tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62750-054
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC ACETATE ANHYDROUS (UNII: H2ZEY72PME) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION2 [hp_X]
    ZINC GLUCONATE (UNII: U6WSN5SQ1Z) (ZINC CATION - UNII:13S1S8SF37) ZINC GLUCONATE1 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    CROSPOVIDONE (120 .MU.M) (UNII: 68401960MK)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MANNITOL (UNII: 3OWL53L36A)  
    AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    ColorPINKScoreno score
    ShapeROUNDSize15mm
    FlavorCHERRYImprint Code Z
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62750-054-101 in 1 CARTON08/01/201210/31/2023
    125 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED HOMEOPATHIC08/01/201210/31/2023
    Labeler - Matrixx Initiatives, Inc. (790037253)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.833150803MANUFACTURE(62750-054)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305MANUFACTURE(62750-054) , PACK(62750-054)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.868734088MANUFACTURE(62750-054) , PACK(62750-054)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464MANUFACTURE(62750-054) , PACK(62750-054)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837MANUFACTURE(62750-054) , PACK(62750-054)

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