Zicam® Cold Remedy Medicated Fruit Drops

Zicam Cold Remedy Medicated Fruit Drops by

Drug Labeling and Warnings

Zicam Cold Remedy Medicated Fruit Drops by is a Homeopathic medication manufactured, distributed, or labeled by Matrixx Initiatives, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ZICAM COLD REMEDY MEDICATED FRUIT DROPS- zinc acetate anhydrous, zinc gluconate, and sambucus nigra flowering top bar, chewable 
Matrixx Initiatives, Inc.

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

----------

Zicam® Cold Remedy Medicated Fruit Drops

Drug Facts

Active ingredients (in each medicated drop)Purpose
  • * Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.
    • Zincum aceticum 2x
    Zincum gluconicum 2x    		Reduces duration and severity of the common cold
    Sambucus nigra (elderberry) 4xHelps relieve cold symptoms*

    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 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: 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 Blue #1, FD&C Red #40, malic acid, menthol, natural flavors, pectin, purified water, sodium citrate, sodium polyphosphate, sucralose, sucrose

    Call 877-942-2626 toll free

    Distributed by
    Matrixx Initiatives, Inc.
    Scottsdale, Arizona 85260

    PRINCIPAL DISPLAY PANEL - 25 Drop Bottle Label

    NEW!

    NDC: 62750-081-10

    plus ELDERBERRY

    ZICAM®
    COLD REMEDY

    SHORTENS COLDS

    TAKE AT THE FIRST
    SIGN OF A COLD

    THE
    PRE-COLD®
    MEDICINE

    MEDICATED
    FRUIT DROPS

    MIXED BERRY FLAVOR

    25 DROPS HOMEOPATHIC

    PRINCIPAL DISPLAY PANEL - 25 Drop Bottle Label
    ZICAM COLD REMEDY MEDICATED FRUIT DROPS 
    zinc acetate anhydrous, zinc gluconate, and sambucus nigra flowering top bar, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 62750-081
    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]
    SAMBUCUS NIGRA FLOWERING TOP (UNII: CT03BSA18U) (SAMBUCUS NIGRA FLOWERING TOP - UNII:CT03BSA18U) SAMBUCUS NIGRA FLOWERING TOP4 [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 BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    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
    ColorPURPLEScoreno score
    ShapeROUNDSize24mm
    FlavorBERRYImprint Code RD
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 62750-081-1025 in 1 BOTTLE; Type 0: Not a Combination Product10/05/201807/20/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED HOMEOPATHIC10/05/201807/20/2019
    Labeler - Matrixx Initiatives, Inc. (790037253)

    Revised: 7/2019
    Document Id: af54398d-c46f-4b6e-ac91-75eaccd454c4
    Set id: 75ac31d8-40d2-400a-a94d-398b8db70dd7
    Version: 2
    Effective Time: 20190712