ZICAM KIDS COLD RELIEF REMEDY (SOFT CHEWS) TABLET, CHEWABLE [BESTCO INC.]

ZICAM KIDS COLD RELIEF REMEDY (SOFT CHEWS) TABLET, CHEWABLE [BESTCO INC.]
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NDC 52642-231-18
Set ID 2c8815e6-5ac4-21c5-e054-00144ff8d46c
Category HUMAN OTC DRUG LABEL
Packager BestCo Inc.
Generic Name
Product Class
Product Number
Application Number
  • ACTIVE INGREDIENT

    Active ingredients (in each soft chew)

    Zincum aceticum 2X

    Zincum gluconicum 2X

  • PURPOSE

    Purpose

    Relieves cold symptoms

  • INDICATIONS & USAGE

    Uses

    • temporarily relieves symptoms of the common cold
    • nasal congestion
    • runny nose
    • scratchy throat
  • WARNINGS

    Zicam Cold Remedy Relief KIDS was formulated to relieve symptoms of the common cold and was not formulated to be effective for flu or allergies.

  • ASK DOCTOR

    Ask a doctor before use if your child has a sensitivity to zinc or is allergic to zinc.

  • STOP USE

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

  • 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 symptoms completely subside
    • children 6-11 years of age (with adult supervision)
    • take 1 soft chew at the onset of symptoms
    • chew thoroughly before swallowing
    • repeat every 3 hours; not to exceed more than 4 doses in 24 hours
    • 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 6 years of age; do not use.
  • OTHER SAFETY INFORMATION

    Other information

    • store between 15-29C (59-84F)
    • avoid freezing and excessive heat
  • INACTIVE INGREDIENT

    Inactive ingredients

    citric acid, corn syrup, corn syrup solids, FD&C blue no. 1, FD&C red no. 40, flavor, glycerin, hydrogenated coconut oil, malic acid, purified water, soy lecithin, sucralose, sucrose

  • PRINCIPAL DISPLAY PANEL

    Zicam Kid Grape SC 18ct

  • INGREDIENTS AND APPEARANCE
    ZICAM KIDS COLD RELIEF REMEDY 
    soft chews tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52642-231
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC ACETATE (UNII: FM5526K07A) (ZINC CATION - UNII:13S1S8SF37) ZINC ACETATE3.54 mg
    ZINC GLUCONATE (UNII: U6WSN5SQ1Z) (ZINC CATION - UNII:13S1S8SF37) ZINC GLUCONATE4.5 mg
    Inactive Ingredients
    Ingredient NameStrength
    SUCROSE (UNII: C151H8M554)  
    Product Characteristics
    ColorpurpleScorescore with uneven pieces
    ShapeRECTANGLESize22mm
    FlavorGRAPEImprint Code NA
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52642-231-1818 in 1 CARTON; Type 0: Not a Combination Product05/06/2014
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic05/06/2014
    Labeler - BestCo Inc. (002149136)
    Registrant - BestCo Inc. (002149136)
    Establishment
    NameAddressID/FEIBusiness Operations
    BestCo Inc.002149136manufacture(52642-231)

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