ZICAM COLD REMEDY MEDICATED FRUIT DROPS (ZINC ACETATE ANHYDROUS AND ZINC GLUCONATE) BAR, CHEWABLE [MATRIXX INITIATIVES, INC.]

ZICAM COLD REMEDY MEDICATED FRUIT DROPS (ZINC ACETATE ANHYDROUS AND ZINC GLUCONATE) BAR, CHEWABLE [MATRIXX INITIATIVES, INC.]
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NDC 62750-080-10
Set ID 04ca2ad5-80df-45d2-bb36-b084d41fb8ce
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 medicated drop)

    Zincum aceticum 2x

    Zincum gluconicum 2x

  • 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 one medicated drop at onset of symptoms
      • chew slowly and dissolve completely before swallowing
      • repeat every 2 – 3 hours, not to exceed 5 medicated drops 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, dextrose, dicalcium phosphate, disodium phosphate, FD&C Red #40, FD&C Yellow #6, malic acid, menthol, natural flavors, pectin, purified water, sodium citrate, sodium polyphosphate, sucralose, sucrose

  • Questions? Comments? Side Effects?

    Call 877-942-2626 toll free.

  • SPL UNCLASSIFIED SECTION

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

  • PRINCIPAL DISPLAY PANEL - 25 Drop Bottle Label

    NEW!

    NDC 62750-080-10

    NATURAL
    ORANGE POWER*

    ZICAM®
    COLD REMEDY

    SHORTENS COLDS

    TAKE AT THE FIRST
    SIGN OF A COLD

    THE
    PRE-COLD®
    MEDICINE

    MEDICATED
    FRUIT DROPS
    *ULTIMATE ORANGE FLAVOR

    25 DROPS • HOMEOPATHIC

    Principal Display Panel - 25 Drop Bottle Label
  • INGREDIENTS AND APPEARANCE
    ZICAM COLD REMEDY MEDICATED FRUIT DROPS 
    zinc acetate anhydrous and zinc gluconate bar, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62750-080
    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)  
    DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)  
    ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
    SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C Yellow NO. 6 (UNII: H77VEI93A8)  
    MALIC ACID (UNII: 817L1N4CKP)  
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
    PECTIN (UNII: 89NA02M4RX)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    SUCROSE (UNII: C151H8M554)  
    Product Characteristics
    ColorORANGEScoreno score
    ShapeROUNDSize24mm
    FlavorORANGEImprint Code Z
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62750-080-1025 in 1 BOTTLE; Type 0: Not a Combination Product03/25/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED HOMEOPATHIC03/25/2019
    Labeler - Matrixx Initiatives, Inc. (790037253)
    Establishment
    NameAddressID/FEIBusiness Operations
    BestCo002149136MANUFACTURE(62750-080)

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