Label: ZINC COLD REMEDY- zinc acetate anhydrous and 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 May 15, 2017

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients Purpose

    Zincum Aceticum 2x

    May reduce duration and severity of cold symptoms**

    Zincum Gluconicum 1x

  • Uses

    may reduce duration of cold symptoms
    may reduce severity of cold symptoms:
    sore throat
    stuffy nose
    sneezing
    coughing
    nasal congestion
  • Warnings

    Ask a doctor before use if you have

    a sensitivity to zinc or are allergic to zinc

    Stop use and ask a doctor if symptoms persist or are accompanied by fever.

    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 ControlCenterright away (1-800-222-1222)

  • Directions

    For best results, use at the first sign of a cold and continue to use until symptoms completely subside.
    adults and children 12 years of age and older:
    take 1 tablet at the onset of symptoms
    dissolve entire tablet in mouth. Do not chew. Do not swallow 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.
    Children under 12 years of age: Consult a doctor before use.
  • Other information

    Store at room temperature
  • Inactive ingredients

    ascorbic acid, crospovidone, FD&C yellow # 6 lake, flavors, magnesium stearate, sorbitol, starch ,sucralose

  • Questions or comments?

    1-866-467-2748

  • SPL UNCLASSIFIED SECTION

  • PRINCIPAL DISPLAY PANEL - 25 Tablet Carton

    NDC 70000-0130-1

    COMPARE TO ZICAM® COLD REMEDY RAPIDMELTS®* active ingredients


    Zinc Cold Remedy

    Zincum Aceticum

    Zincum Gluconicum

    Citrus
    Flavor

    Naturally and Artificially Flavored

    May reduce duration and severity of cold symptoms**

    Fast -Melting Tablets with Vitamin C

    Homeopathic

    25 QUICK- DISSOLVING TABLETS

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

    **This statement has not been evaluated by the Food and Drug Administration, This product is not intended to diagnose, treat, cure or prevent any disease.

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

     
    © 2017 CARDINAL HEALTH, the Cardinal Health LOGO, LEADER, and the Leader LOGO
     
    are trademarks or registered trademarks of Cardinal Health.
     
    CARDINAL HEALTH
     
    DISTRIBUTED BY CARDINAL HEALTH

    DUBLIN, OHIO 43017

    www.myleader.com

    1-800-200-6313

    Essential to Care™ since 1979

    All Leader Brand Products have a 100% Money Back Guarantee

    Return to place of purchase if not satisfied

     Leader Zinc Cold Remedy Citrus  Flavor 25 Quick Dissolving  tablets
  • INGREDIENTS AND APPEARANCE
    ZINC COLD REMEDY 
    zinc acetate anhydrous and zinc gluconate tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0130
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC ACETATE ANHYDROUS (UNII: H2ZEY72PME) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION2 [hp_X]
    ZINC GLUCONATE (UNII: U6WSN5SQ1Z) (ZINC CATION - UNII:13S1S8SF37) ZINC GLUCONATE1 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    ascorbic acid (UNII: PQ6CK8PD0R)  
    crospovidone (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:70000-0130-125 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/15/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Unapproved homeopathic05/15/2017
    Labeler - CARDINAL HEALTH (097537435)