Label: FIRST AID DIRECT COLD-EEZE COLD REMEDY- zinc gluconate lozenge

  • NDC Code(s): 42961-105-01, 42961-105-02
  • Packager: Cintas Corporation
  • 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 July 20, 2023

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

View All Sections
  • ACTIVE INGREDIENT

    Active ingredient (per lozenge)

    Zinc Gluconate 2X HPUS† (2.3%) 13.3 mg zinc)

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

  • PURPOSE

    Purpose

    Cold remedy

  • INDICATIONS & USAGE

    Uses

    • reduces the duration of the common cold
    • reduces the severity of cold symptoms: cough, sore throat, nasal congestion, post nasal drip and/or hoarseness
  • Warnings

    Do not use for treatment of influenza or allergies. This product is intended only to reduce the duration of the common cold and its symptoms

    Ask a doctor or pharmacist before use if you are taking minocycline, doxycycline, tetracycline or are on Coumadin (warfarin) therapy. Zinc treatment may inhibit the absorption of these medicines. 

    When using this product do not take on an empty stomach (to avoid possible minor stomach upset)

    Stop use and ask your doctor if symptoms persist more than 7 days

    If pregnant or breastfeeding, ask a healthcare professional before use.

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

  • DOSAGE & ADMINISTRATION

    Directions

    • take one lozenge at the onset of symptoms
    • dissolve entire lozenge in mouth
    • do not chew
    • do not swallow whole
    • do not eat or drink for 15 minutes after use
    • repeat every 2-4 hours until symptoms subside
    • Adults 18 years and over: do not exceed 6 lozenges per day
    • Children 12 to under 18 years: do not exceed 4 lozenges per day
    • Children under 12 years: ask a doctor before use
  • OTHER SAFETY INFORMATION

    Other information

    • store in a cool, dry place after opening
    • best if used within 6 months after opening
  • INACTIVE INGREDIENT

    Inactive ingredients

    corn syrup, glycine, natural flavors, sucrose

  • QUESTIONS

    Questions?

    1-800-327-2704 m-F 8am-5pm EST

  • Principal Display Panel

    Cold-EEZE®

    Cold Remedy Lozenge

    Zinc Gluconate Homeeopathic

    NATURAL CHERRY FLAVOR

    Formulated to reduce the duration of the common cold when taken at the first sign of symptoms.

    20 Lozenges per box

    Cold-EEZE® is a registered trademark of Vespyr Brands®, Inc.

    1192000

    Box_Label

  • INGREDIENTS AND APPEARANCE
    FIRST AID DIRECT COLD-EEZE COLD REMEDY 
    zinc gluconate lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42961-105
    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
    CORN SYRUP (UNII: 9G5L16BK6N)  
    GLYCINE (UNII: TE7660XO1C)  
    SUCROSE (UNII: C151H8M554)  
    CHERRY (UNII: BUC5I9595W)  
    Product Characteristics
    Colorwhite (Semi-Translucent) Scoreno score
    ShapeOVALSize23mm
    FlavorCHERRYImprint Code P
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42961-105-0220 in 1 PACKAGE07/20/2023
    1NDC:42961-105-011 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic07/20/2023
    Labeler - Cintas Corporation (056481716)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharmaloz Manufacturing, Inc.067101998manufacture(42961-105)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!