Label: ZICAM COLD REMEDY SOFT CHEWS- zincum aceticum, zincum gluconicum, caffeinum tablet, chewable

  • 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 February 24, 2016

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Active ingredients (in each soft chew)

    Zincum aceticum 2X

    Zincum gluconicum 1X

    Caffeinum 5X

  • PURPOSE

    Purpose

    Reduces duration and severity of the common cold

    Helps restore mental alertness

  • INDICATIONS & USAGE

    Uses

    • reduces duration of the common cold
    • reduces severity of cold symptoms: sore throat, stuffy nose, sneezing, coughing, nasal congestion
    • helps restore mental alertness when experiencing fatigue or drowsiness
  • WARNINGS

    Zicam Cold Remedy was formulated to shorten the duration of the common cold and was not formulated to be effective for flu or allergies.

  • ASK DOCTOR

    Ask a doctor before use if you have a sensitivity to zinc or are allergic to zinc

  • STOP USE

    Stop use and ask a doctor if symptoms persist or are accompanied by a fever or new symptoms occur

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • OVERDOSAGE

    In case of overdose, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions

    • for best results, use at the first sign of a cold and continue to use until to use until symptoms completely subside
    • adults and children 12 years of age and older:
    • take 2 soft chews at the onset of symptoms
    • chew thoroughly before swallowing
    • repeat every 2-6 hours, not to exceed 4 doses in 24 hours. Take until symptoms are gone.
    • to avoid minor stomach upset, do not take on any 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 SAFETY INFORMATION

    Other information

    • store between 15-29C (59-84F)
  • INACTIVE INGREDIENT

    Inactive ingredients

    cocoa powder, coconut oil, corn syrup, corn syrup solids, glycerin, natural and artificial flavors, purified water, soy lecithin, sucralose, sucrose

  • PRINCIPAL DISPLAY PANEL

    Zicam Vitality SC 32ct

  • INGREDIENTS AND APPEARANCE
    ZICAM COLD REMEDY SOFT CHEWS 
    zincum aceticum, zincum gluconicum, caffeinum tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52642-232
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC ACETATE (UNII: FM5526K07A) (ZINC CATION - UNII:13S1S8SF37) ZINC ACETATE3.53 mg
    CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE0.03 mg
    ZINC GLUCONATE (UNII: U6WSN5SQ1Z) (ZINC CATION - UNII:13S1S8SF37) ZINC GLUCONATE4.47 mg
    Inactive Ingredients
    Ingredient NameStrength
    SUCROSE (UNII: C151H8M554)  
    Product Characteristics
    ColorbrownScorescore with uneven pieces
    ShapeRECTANGLESize20mm
    FlavorCHOCOLATEImprint Code NA
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52642-232-3232 in 1 CARTON; Type 0: Not a Combination Product04/20/2015
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic04/20/2015
    Labeler - BestCo Inc. (002149136)
    Registrant - BestCo Inc. (002149136)
    Establishment
    NameAddressID/FEIBusiness Operations
    BestCo Inc.002149136manufacture(52642-232)