Label: ZICAM ULTRA COLD REMEDY RAPIDMELTS- zinc acetate anhydrous and zinc gluconate tablet

  • NDC Code(s): 10237-478-18
  • 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 December 28, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients (in each tablet)

    Zincum aceticum 2x
    Zincum gluconicum 1x

  • Purpose

    Reduces duration of the common cold and helps relieve nasal congestion

  • Uses

    • Reduces duration of the common cold and helps relieve nasal congestion

    Zicam® ULTRA Cold Remedy was not formulated to be effective for flu or allergies.

  • Warnings

    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 tablet at the onset of symptoms
      • dissolve entire tablet in mouth. Do not chew. Do not 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)
  • Inactive ingredients

    crospovidone, flavor, magnesium stearate, mannitol, monoammonium glycyrrhizinate, sodium starch glycolate, stearic acid, sucralose

  • Questions? Comments?

    call 877-942-2626 toll free
    www.zicam.com

  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY CHURCH & DWIGHT CO., INC.
    EWING, NJ 08628

  • PRINCIPAL DISPLAY PANEL - 18 Tablet Bottle Carton

    ZICAM®
    COLD REMEDY

    SHORTENS COLDS

    ULTRA

    SUGAR-FREE
    DYE-FREE

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

    RAPIDMELTS®

    Cherry Flavor

    18
    Quick Dissolve
    TABLETS

    HOMEOPATHIC

    PRINCIPAL DISPLAY PANEL - 18 Tablet Bottle Carton
  • INGREDIENTS AND APPEARANCE
    ZICAM ULTRA COLD REMEDY RAPIDMELTS 
    zinc acetate anhydrous and zinc gluconate tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10237-478
    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 GLUCONATE1 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    CROSPOVIDONE (120 .MU.M) (UNII: 68401960MK)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MANNITOL (UNII: 3OWL53L36A)  
    AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeROUNDSize15mm
    FlavorCHERRYImprint Code ZZ
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10237-478-181 in 1 CARTON02/18/2022
    118 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED HOMEOPATHIC02/18/2022
    Labeler - CHURCH & DWIGHT CO., INC. (001211952)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.833150803MANUFACTURE(10237-478)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305MANUFACTURE(10237-478) , PACK(10237-478)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.868734088MANUFACTURE(10237-478) , PACK(10237-478)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464MANUFACTURE(10237-478) , PACK(10237-478)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837MANUFACTURE(10237-478) , PACK(10237-478)
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