Label: NBE COOL MINT COLD REMEDY FAST MELTING- zinc gluconate lozenge

  • 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 August 24, 2011

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient (in each tablet)

    Zincum Gluconicum 1X

  • Purpose

    Reduces duration and severity of the common cold

  • Uses

    • Reduces duration of common cold
    • Reduces severity of cold symptoms: stuffy nose, sneezing, sore throat, coughing, and congestion
  • Warnings

    • Stop use and ask doctor if
      • Side effects occur. You may report side effects to FDA at 1-800-FDA-1088.
    • Cold Remedy PLUS is formulated to reduce the duration and severity of the common cold and may not be effective for flu or allergies.

    Stop use and ask a doctor if symptoms persist.

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

    Keep out of reach of children.

  • Directions

    For Adults and Children 12 years old and older:

    Note: For maximum benefit, begin treatment at first sign of cold.

    • Completely dissolve entire tablet in mouth. Do not chew. Do not swallow whole.
    • Take one tablet at the onset of symptoms.
    • Repeat every three hours until symptoms are gone, up to 5 tablets per day.
    • For best results, use for an additional 48 hours after symptoms subside.
    • 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.

    For Children under 12 years of age, consult a physician before use.

  • Inactive Ingredients

    Copovidone, Crospovidone, Magnesium Stearate, Mannitol, Menthol, Mono-Ammonium Glycyrrhizinate, Natural and Artificial Flavors, Silicon Dioxide, Sodium Starch Glycolate, Sorbitol, Stearic Acid, Sucralose

  • SPL UNCLASSIFIED SECTION

    Distributed by:
    CVS Pharmacy, Inc.
    One CVS Drive,
    Woonsocket, RI 02895

  • PRINCIPAL DISPLAY PANEL - 25 Tablet Bottle Carton

    CVS®
    pharmacy

    Compare to
    the active ingredient
    in Zicam® Rapid Melts®
    Cold Remedy PLUS†

    NEW!

    COLD
    REMEDY
    PLUS
    FAST MELTING

    ZINC GLUCONICUM

    Cool Mint
    Homeopathic

    Take at the first
    sign of a cold

    • Reduces the duration &
      severity of the common cold
    • Menthol helps relieve stuffy nose
    • No metallic aftertaste

    25
    Quick dissolving
    tablets

    Principal Display Panel - 25 Tablet Bottle Carton
  • INGREDIENTS AND APPEARANCE
    NBE COOL MINT   COLD REMEDY FAST MELTING
    zinc gluconate lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64762-884
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC GLUCONATE (UNII: U6WSN5SQ1Z) (ZINC - UNII:J41CSQ7QDS) ZINC GLUCONATE1 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    Menthol (UNII: L7T10EIP3A)  
    Copovidone K25-31 (UNII: D9C330MD8B)  
    Crospovidone (UNII: 68401960MK)  
    Magnesium Stearate (UNII: 70097M6I30)  
    Mannitol (UNII: 3OWL53L36A)  
    Ammonium Glycyrrhizate (UNII: 3VRD35U26C)  
    Silicon Dioxide (UNII: ETJ7Z6XBU4)  
    Sodium Starch Glycolate Type A Potato (UNII: 5856J3G2A2)  
    Sorbitol (UNII: 506T60A25R)  
    Stearic Acid (UNII: 4ELV7Z65AP)  
    Sucralose (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeROUNDSize7mm
    FlavorMINTImprint Code CH
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64762-884-251 in 1 CARTON
    125 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED HOMEOPATHIC08/01/2011
    Labeler - Dynamic Pharmaceuticals Inc. (617660712)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dynamic Pharmaceuticals Inc.617660712MANUFACTURE
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