Label: ZINC COLD THERAPY- zinc gluconate tablet, chewable

  • NDC Code(s): 21130-881-25
  • Packager: BETTER LIVING BRANDS LLC
  • 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 February 12, 2018

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • ACTIVE INGREDIENT

    Active ingredient (in each tablet) Purpose

    Cold Remedy

    Zincum Gluconicum 1x(11 mgZinc)

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  • 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.
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  • 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 ControlCenterright away at 1-800-222-1222

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  • 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.
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  • Other information

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

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

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  • Questions or comments?

    1-866-467-2748

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  • PRINCIPAL DISPLAY PANEL

    *COMPARE TO Zicam® Cold Remedy Rapidmelts®* Ionizable Zinc Content*

    Signature Care ™

    Quality Guaranteed


    Zinc Cold Therapy

    ZINCUM GLUCONICUM

    CITRUS FLAVOR

    Naturally and Artificially Flavored

     
    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 OR 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® .

    DISTRIBUTED BY BETTER LIVING BRANDS LLC

    P.O BOX 99, PLEASANTON, CA 94566-0009

    1-888-723-3929

    www.betterlivingbrandsLLC.com

    Zinc Cold Therapy Citrus Flavor 25 Chewable Tablets
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  • INGREDIENTS AND APPEARANCE
    ZINC COLD THERAPY 
    zinc gluconate tablet, chewable
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:21130-881
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ZINC GLUCONATE (UNII: U6WSN5SQ1Z) (ZINC CATION - UNII:13S1S8SF37) ZINC GLUCONATE 1 [hp_X]
    Inactive Ingredients
    Ingredient Name Strength
    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
    Color ORANGE Score no score
    Shape ROUND (Biconcave) Size 16mm
    Flavor CITRUS Imprint Code r8
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:21130-881-25 25 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/28/2018
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    Unapproved homeopathic 02/28/2018
    Labeler - BETTER LIVING BRANDS LLC (009137209)
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