Label: ZINC COLD THERAPY- zinc gluconate tablet

  • 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 October 4, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient (in each tablet)Purpose

    Cold Remedy

    Zincum Gluconicum 1x(11 mg Zinc)
  • Uses

    ▪
    may help reduce duration and severity of cold symptoms
    ▪
    sore throat
    ▪
    stuffy nose
    ▪
    sneezing
    ▪
    coughing
     
    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

    Ask a doctor before use if you have

    ▪
    a sensitivity to zinc or are allergic to zinc
    ▪
    are taking minocycline, doxycycline, tetracycline or are on Coumadin therapy, zinc treatment may inhibit the absorption of these medicines.

    Stop use and ask a doctor if symptoms persist beyond 7 days.

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

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222

  • Directions

    ▪
    For best results, use at the first sign of a cold and continue to use as directed
    ▪
    adults and children 12 years of age and older:
    ▪
    chew one tablet at the onset of symptoms
    ▪
    repeat every 3 hours until symptoms are gone
    ▪
    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
    ▪
    recommended daily dose is 6 tablets for adults and 4 tablets for ages 12 through 17
    ▪
    Children under 12 years of age: Consult a doctor before use.
  • Other information

    ▪
    do not take zinc tablets on an empty stomach to avoid possible minor stomach upset.
    ▪
    store at room temperature
  • Inactive ingredients

    ascorbic acid, crospovidone, FD&C yellow # 6 lake, magnesium stearate, natural and artificial flavor sorbitol, starch, sucralose

  • Questions or comments?

    1-866-467-2748

  • PRINCIPAL DISPLAY PANEL

    COMPARE TO ZICAM® COLD REMEDY RAPID MELTS Ionizable Zinc Content *
    Zinc Cold Therapy

    Zincum Gluconicum

    Citrus
    Flavor

    Naturally and Artificially Flavored

    May help reduce duration and severity of cold symptoms**

     
    Sugar Free
     
    Homeopathic†

    25 CHEWABLE TABLETS

    DO NOT USE IF PRINTED INNER SEAL UNDER CAP IS BROKEN OR MISSING

    **THIS PRODUCT IS A HOMEOPATHIC REMEDY, AS SUCH, IT HAS NOT UNDERGONE REVIEW ON APPROVAL BY THE FDA AND THEREFORE HAS NOT BEEN DEMONSTRATED TO BE SAFE OR EFFECTIVE TO DIAGNOSE, TREAT, PREVENT, MITIGATE OR CURE ANY CONDITION OR DISEASE.

    †CLAIM IS BASED ONLY ON THEORIES OF HOMEOPATHY FROM 1700S NOT ACCEPTED BY MOST MODERN MEDICAL EXPERTS. THERE IS NO SCIENTIFIC EVIDENCE THAT THE PRODUCT WORKS

    IMPORTANT: Keep this carton for future reference on full labeling.

    *This product is not manufactured or distributed by Matrixx Initiatives, Inc, owner of the registered trademarks Zicam® Cold Remedy Rapidmelts®

     
    CardinalHealth™

    DISTRIBUTED BY CARDINAL HEALTH

    DUBLIN,OHIO 43017

    www.myleader.com 1-800-200-6313

    Essential to care ™ since 1979

    Leader Zinc Cold Therapy Citrus Flavor 25 Chewable Tablets
  • INGREDIENTS AND APPEARANCE
    ZINC COLD THERAPY 
    zinc gluconate tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0391
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC GLUCONATE (UNII: U6WSN5SQ1Z) (ZINC CATION - UNII:13S1S8SF37) ZINC GLUCONATE1 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    ascorbic acid (UNII: PQ6CK8PD0R)  
    CROSPOVIDONE (120 .MU.M) (UNII: 68401960MK)  
    FD&C Yellow No. 6 (UNII: H77VEI93A8)  
    magnesium stearate (UNII: 70097M6I30)  
    SORBITOL (UNII: 506T60A25R)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    sucralose (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    ColorORANGEScoreno score
    ShapeROUND (Biconcave) Size16mm
    FlavorCITRUSImprint Code r8
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70000-0391-125 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/10/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Unapproved homeopathic05/10/2018
    Labeler - CARDINAL HEALTH (063997360)
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