Label: ZICAM COLD REMEDY ZINC AND ELDERBERRY LOZENGE- zinc acetate anhydrous, zinc gluconate, and sambucus nigra flowering top lozenge

  • NDC Code(s): 10237-462-25
  • Packager: Church & Dwight Co., Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

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.

Drug Label Information

Updated January 2, 2024

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  • Active ingredients (in each lozenge)

    Zincum aceticum 2x

    Zincum gluconicum 2x

    Sambucus nigra (elderberry) 4x

  • Purpose

    Active ingredients (in each tablet)Purpose
    *
    Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.
    Zincum aceticum 2x



    Zincum gluconicum 2x     		Reduces duration of the common cold and helps relieve nasal congestion
    Sambucus nigra (elderberry) 4xHelps relieve cold symptoms *
  • Uses

    Reduces duration of the common cold and helps relieve nasal congestion

    ------------------------------------------------------------------------------------------------------

    Zicam ® Cold Remedy was not formulated to be effective for flu and 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.

    If you are allergic or sensitive to zinc, consult a doctor before using.

    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 tablet at the onset of symptoms. Completely dissolve lozenge in mouth. Do not chew. Do now 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)
    • avoid freezing and excessive heat
  • Inactive ingredients

    citric acid, corn syrup, FD&C Blue No. 1, FD&C Red No. 40, flavor, glycerin, malic acid, purified water, soy lecithin, sucralose, sucrose

  • Questions? Comments?

    call 877-942-2626 toll free

    www.zicam.com

  • PRINCIPAL DISPLAY PANEL - 25 INDIVIDUALLY WRAPPED CENTER FILLED LOZENGES

    NEW!

    Plus ELDERBERRY

    ZICAM®

    COLD REMEDY

    PRE-COLD®

    FIGHTER

    ZINC &

    ELDERBERRY

    LOZENGE

    Elderberry Flavor

    HOMEOPATHIC

    TAKE AT

    THE FIRST SIGN

    25 INDIVIDUALLY WRAPPED

    CENTER FILLED

    LOZENGES

    7404 ZicLozElderberry25ctCrtn-FNL_AR.jpg

  • INGREDIENTS AND APPEARANCE
    ZICAM   COLD REMEDY ZINC AND ELDERBERRY LOZENGE
    zinc acetate anhydrous, zinc gluconate, and sambucus nigra flowering top lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10237-462
    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 ACETATE (UNII: DSO12WL7AU)  
    CORN SYRUP (UNII: 9G5L16BK6N)  
    WATER (UNII: 059QF0KO0R)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MALIC ACID (UNII: 817L1N4CKP)  
    SUCROSE (UNII: C151H8M554)  
    Product Characteristics
    ColorPURPLEScoreno score
    ShapeROUNDSize15mm
    FlavorBERRYImprint Code Z
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10237-462-251 in 1 CARTON08/02/2021
    125 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED HOMEOPATHIC08/02/2021
    Labeler - Church & Dwight Co., Inc. (001211952)
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