Label: GOODSENSE CHERRY ZINC LOZENGES- zinc gluconate glycine 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 June 30, 2021

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  • ACTIVE INGREDIENT

    Active ingredient (in each lozenge)

    Zincum Gluconicum 2X HPUS**

    **The letters "HPUS" indicate that the active ingredient is in the official Homeopathic Pharmacopeia of the United States.

  • PURPOSE

    Purpose

    Cold Relief

  • INDICATIONS & USAGE

    Uses

    • reduce the duration of nasal congestion and shorten the length of the common cold
  • 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 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 avoid minor stomach upset, do not dissolve lozenges on an empty stomach
    • avoid citrus fruits 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 the start of symptoms (within 24 - 48 hours of onset)
    • completely dissolve lozenge 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
    • Zinc content per lozenge: 13.3 mg
  • INACTIVE INGREDIENT

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

  • QUESTIONS

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

  • PRINCIPAL DISPLAY PANEL

    GoodSense Cherry Zinc 18ct Lozenge

  • INGREDIENTS AND APPEARANCE
    GOODSENSE CHERRY ZINC LOZENGES 
    zinc gluconate glycine lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75981-011
    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
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Colorwhite (Semi-translucent) Scoreno score
    ShapeOVALSize22mm
    FlavorCHERRYImprint Code B
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75981-011-1818 in 1 BOX; Type 0: Not a Combination Product06/30/2021
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic06/30/2021
    Labeler - Geiss, Destin, & Dunn (076059836)
    Registrant - Bestco LLC (002149136)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bestco LLC002149136manufacture(75981-011)
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