Label: ZICAM COLD AND FLU-LIKE SYMPTOMS ECHINACEA PLUS SAMBUCUS- zinc acetate anhydrous, zinc gluconate, echinacea angustifolia whole, and sambucus nigra flowering top tablet, multilayer

  • NDC Code(s): 10237-479-20
  • Packager: CHURCH AND 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 June 5, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active Ingredients (in each tablet)Purpose
    *
    Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.
    Echinacea angustifolia 5xHelps to relieve cold and flu-like symptoms*
    Sambucus nigra (elderberry) 5xHelps to relieve cold and flu-like symptoms*
    Zincum aceticum 2x
    Zincum gluconicum 1x    		Reduces duration of the common cold and helps relieve nasal congestion
  • Uses

    Reduces duration of the common cold and helps relieve nasal congestion and temporarily relieves

    • Fever
    • Chills
    • Chest Congestion
    • Hoarseness
    • Cough
    • Sore throat
    • Body aches
  • Warnings

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

    Sore throat warning

    If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomitting, consult a doctor promptly.

    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 cold and flu 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, FD&C Blue No. 2 aluminum lake, FD&C Yellow No. 6 aluminum lake, flavors, magnesium stearate, mannitol, mono-ammonium glycyrrhizinate, silicon dioxide, sodium starch glycolate, stearic acid, sucralose.

  • Questions? Comments?

    call 877-942-2626 toll free

  • SPL UNCLASSIFIED SECTION

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

  • PRINCIPAL DISPLAY PANEL - 20 Tablet Blister Pack Carton

    NEW!
    ZICAM®

    COLD & FLU-LIKE SYMPTOMS‡

    ECHINACEA + SAMBUCUS

    HELPS
    WITH
    6
    SYMPTOMS‡

    ✓ COUGH
    ✓ HOARSENESS

    ✓ SORE THROAT
    ✓ BODY ACHES

    ✓ CHEST CONGESTION
    ✓ FEVER & CHILLS

    Plus Zinc to help relieve nasal congestion

    HOMEOPATHIC

    20
    QUICK-DISSOLVE
    TABLETS

    COOLING
    PEPPERMINT FLAVOR

    ‡Claims based on traditional homeopathic practice,
    not accepted medical evidence. Not FDA evaluated.

    PRINCIPAL DISPLAY PANEL - 20 Tablet Blister Pack Carton
  • INGREDIENTS AND APPEARANCE
    ZICAM COLD AND FLU-LIKE SYMPTOMS   ECHINACEA PLUS SAMBUCUS
    zinc acetate anhydrous, zinc gluconate, echinacea angustifolia whole, and sambucus nigra flowering top tablet, multilayer
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10237-479
    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]
    ECHINACEA ANGUSTIFOLIA WHOLE (UNII: VB06AV5US8) (ECHINACEA ANGUSTIFOLIA WHOLE - UNII:VB06AV5US8) ECHINACEA ANGUSTIFOLIA WHOLE5 [hp_X]
    SAMBUCUS NIGRA FLOWERING TOP (UNII: CT03BSA18U) (SAMBUCUS NIGRA FLOWERING TOP - UNII:CT03BSA18U) SAMBUCUS NIGRA FLOWERING TOP5 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    CROSPOVIDONE (120 .MU.M) (UNII: 68401960MK)  
    FD&C BLUE NO. 2--ALUMINUM LAKE (UNII: 4AQJ3LG584)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    MANNITOL (UNII: 3OWL53L36A)  
    AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    ColorORANGE, BLUEScoreno score
    ShapeROUNDSize15mm
    FlavorPEPPERMINTImprint Code ZZ
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10237-479-201 in 1 CARTON07/01/2023
    120 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Unapproved homeopathic07/01/2023
    Labeler - CHURCH AND DWIGHT CO, INC. (001211952)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.833150803MANUFACTURE(10237-479)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305MANUFACTURE(10237-479) , PACK(10237-479)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.868734088MANUFACTURE(10237-479) , PACK(10237-479)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464MANUFACTURE(10237-479) , PACK(10237-479)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837MANUFACTURE(10237-479) , PACK(10237-479)
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