Label: CVS HEALTH COLD REMEDY CITRUS FLAVOR- 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 September 12, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

    Active Ingredient

    Zincum Gluconicum 1x (11mg Zinc)

    Purpose

    Cold Remedy

  • Uses

    ▪
    may help reduce duration 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 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

    As ask 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 completely at the onset of symptoms. Do not swallow tablets whole.
    ▪
    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 No. 6, magnesium stearate, flavors, sorbitol, starch ,sucralose.

  • Questions or comments?

    1-866-467-2748

  • PRINCIPAL DISPLAY PANEL

    CVS Health™

    NDC 69842-688-25

    *Compare to Zicam® Cold Remedy Rapid Melts® Ionizable Zinc Content**

    SUGAR FREE

    Non-Drowsy
    Cold Remedy

    ZINCUM GLUCONICUM

    •
    Take at the first sign of a cold
    •
    May help reduce the duration of cold symptoms*
    •
    Non-habit forming
    •
    No known drug interactions

    Citrus Flavor

    Homeopathic†

    25 CHEWABLE TABLETS

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

    †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

    **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.

    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®
    Distributed by:

    CVS Pharmacy, Inc.

    One CVS Drive

    Woonsocket, RI 02895

    © 2019 CVS/pharmacy

    CVS.com® 1-800-SHOP CVS

    V-12431

    CVS Quality Money Back Guarantee

    CVS Helth Non Drowsy COld Remedy Citrus Flavor
  • INGREDIENTS AND APPEARANCE
    CVS HEALTH COLD REMEDY  CITRUS FLAVOR
    zinc gluconate tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-688
    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:69842-688-2525 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/18/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Unapproved homeopathic04/18/2019
    Labeler - CVS PHARMACY, INC (062312574)
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