Label: ZICAM COLD REMEDY- zinc acetate anhydrous and zinc gluconate lozenge

  • NDC Code(s): 10237-473-25
  • 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 March 28, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients (in each lozenge)

    Zincum aceticum 2x

    Zincum gluconicum 2x

  • Purpose

    Reduces duration of the common cold and helps relieve nasal congestion

  • Uses

    • reduces duration of the common cold and helps relieve nasal congestion
    • soothes sore throats and coughs

    Zicam ® Cold Remedy 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.

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

    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 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, flavors, malic acid, purified water, sucralose, sucrose

  • PRINCIPAL DISPLAY PANEL - 25 Lozenge Pouch Carton

    ZICAM ®


    COLD REMEDY

    SHORTENS COLDS

    SOOTHES SORE THROATS
    AND COUGHS +

    GREAT TASTING!

    TAKE AT THE FIRST
    SIGN OF A COLD

    THE
    PRE-COLD ®
    MEDICINE

    SHORTENS COLDS

    LOZENGES

    Wild Cherry Flavor

    HOMEOPATHIC

    25
    Individually Wrapped
    LOZENGES

    Zicam Lozenges - Wild Cherry.jpg

  • INGREDIENTS AND APPEARANCE
    ZICAM COLD REMEDY 
    zinc acetate anhydrous and zinc gluconate lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10237-473
    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)  
    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:10237-473-251 in 1 CARTON03/28/2022
    125 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic03/28/2022
    Labeler - Church & Dwight Co., Inc. (001211952)
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