Label: COLD RELIEF- zinc gluconate lozenge

  • 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, 2021

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

  • ACTIVE INGREDIENT

    Active ingredient (in each lozenge)

    Zincum Gluconicum 2X (13.4 mg)

  • PURPOSE

    Purpose

    Cold Relief

  • INDICATIONS & USAGE

    Uses

    • may help reduce the duration of common cold symptoms
    • this product was formulated to help reduce the duration and severity of cold symptoms and was not formulated to be effective for flu or allergies
  • WARNINGS

    Warnings

    Ask a doctor before use if you have a sensitivity to zinc or are allergic to zinc or any of the other ingredients in this product

  • ASK DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if you are now taking minocycline, doxycycline, tetracycline or are on coumadin therapy; zinc treatment may inhibit the absorption of these medicines

  • WHEN USING

    When using this product

    to avaid minor stomach upset, do not dissolve lozenges on an empty stomach

    avoid citrus fruits or juices and products containing citric acid 1/2 hour before or after taking, as they may diminish effectiveness

  • STOP USE

    Stop use and ask a doctor if symptoms persist for more than 7 days or are accompanied by a fever

  • 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.

  • DOSAGE & ADMINISTRATION

    Directions

    adults and children 12 years and over

    for best results, begin treatment at start of symptoms (within 24 - 48 hours of onset)

    completely dissolve lozenges in mouth. (Do not swallow whole. Do not chew.)

    repeat every 2 - 4 hours as needed until symptoms subside

    do not exceed 6 lozenges for adults and 4 lozenges for children ages 12 - 17 in a 24 hour period

    for children under 12 years of age, consult a health professional prior to use

  • OTHER SAFETY INFORMATION

    Other information

    not formulated to be effective for treatment of influenza or allergies

    store in a cool dry place after opening

    no artificial colors or preservatives

  • INACTIVE INGREDIENT

    Inactive ingredients: Corn starch, corn syrup, glycine, medium chain triglycerides, natural flavors, purified water, soybean oil and sucrose.

  • QUESTIONS

    Questions? Or to report an adverse event call 1-800-245-2898. Monday through Friday, 9AM to 4PM EST

  • PRINCIPAL DISPLAY PANEL

    Walgreens Cherry Zinc 18ct Lozenge

  • INGREDIENTS AND APPEARANCE
    COLD RELIEF 
    zinc gluconate lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-1090
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC GLUCONATE (UNII: U6WSN5SQ1Z) (ZINC CATION - UNII:13S1S8SF37) ZINC GLUCONATE2 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    SUCROSE (UNII: C151H8M554)  
    Product Characteristics
    Colorwhite (Semi-Translucent) Scoreno score
    ShapeOVALSize16mm
    FlavorCHERRYImprint Code B
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-1090-1818 in 1 CARTON; Type 0: Not a Combination Product06/11/2015
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic06/11/2015
    Labeler - Walgreen Company (008965063)
    Registrant - Bestco Inc. (002149136)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bestco Inc.002149136manufacture(0363-1090)