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

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ZICAM COLD REMEDY (ZINC ACETATE ANHYDROUS AND ZINC GLUCONATE) LOZENGE [MATRIXX INITIATIVES, INC.]
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NDC 62750-079-10
Set ID ac7e37b9-182e-4297-a69c-eef3bdd3fc70
Category HUMAN OTC DRUG LABEL
Packager Matrixx Initiatives, Inc.
Generic Name
Product Class
Product Number
Application Number
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients (in each lozenge)

    Zincum aceticum 2x

    Zincum gluconicum 2x

  • Purposes

    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

    Sore throat warning

    If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

    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, including cough, persist, recur or are accompanied by a fever, rash, or persistent headache, or if new symptoms occur. A persistent cough that lasts for more than one week may be a sign of a serious condition.

    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 lozenge at the onset of symptoms. Completely dissolve lozenge in mouth. Do not chew. Do not swallow whole.
      • repeat every 2 – 3 hours, not to exceed 7 lozenges 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)
    • avoid freezing and excessive heat
  • Inactive ingredients

    citric acid, corn syrup, FD&C blue no. 1, FD&C red no. 40, malic acid, menthol, natural flavors, purified water, sucralose, sucrose

  • SPL UNCLASSIFIED SECTION

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

  • PRINCIPAL DISPLAY PANEL - 25 Lozenge Pouch Carton

    NDC 62750-079-10

    ZICAM®
    COLD REMEDY

    SHORTENS COLDS
    + SOOTHES SORE THROATS
    AND COUGHS

    TAKE AT THE FIRST
    SIGN OF A COLD
    THE
    PRE-COLD®
    MEDICINE

    CLINICALLY PROVEN
    TO SHORTEN COLDS

    LOZENGES

    GREAT TASTING

    Wild Cherry Flavor

    HOMEOPATHIC
    25
    Individually Wrapped
    LOZENGES

    Principal Display Panel - 25 Lozenge Pouch Carton
  • INGREDIENTS AND APPEARANCE
    ZICAM COLD REMEDY 
    zinc acetate anhydrous and zinc gluconate lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62750-079
    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 GLUCONATE2 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    CORN SYRUP (UNII: 9G5L16BK6N)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    MALIC ACID (UNII: 817L1N4CKP)  
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
    WATER (UNII: 059QF0KO0R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    SUCROSE (UNII: C151H8M554)  
    Product Characteristics
    ColorREDScoreno score
    ShapeOVALSize22mm
    FlavorCHERRYImprint Code Z
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62750-079-101 in 1 CARTON02/01/2018
    125 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED HOMEOPATHIC02/01/2018
    Labeler - Matrixx Initiatives, Inc. (790037253)
    Establishment
    NameAddressID/FEIBusiness Operations
    BestCo002149136MANUFACTURE(62750-079)
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