Label: NBB CITRUS- zinc gluconate, zinc oxide, and sambucus nigra flower tablet, orally disintegrating

  • 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 January 5, 2010

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active Ingredients (in each tablet)Purpose
    Zincum Oxydatum 1XReduces duration
    Zincum Gluconicum 1Xand severity of the
    Sambucus nigra 1Xcommon 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 is formulated to shorten 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 6 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 6 years of age, consult a physician before use.

  • Inactive Ingredients

    Gluten Free

    Ascorbic Acid, Copovidone, Crospovidone, Magnesium Stearate, Mannitol, Mono-Ammonium Glycyrrhizinate, Natural & Artificial Citrus 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 carton

    CVS®
    pharmacy

    Compare to
    Zicam® RapidMelts®
    Cold Remedy with Vitamin C*

    NEW!

    COLD
    REMEDY
    FAST MELTING

    ZINCUM OXYDATUM
    ZINCUM GLUCONICUM
    SAMBUCUS NIGRA

    Citrus + C
    Homeopathic

    Take at the first
    sign of a cold

    • Shortens the duration & severity
      of the common cold
    • No metallic aftertaste

    25
    Quick dissolving
    tablets

    Principal Display Panel - 25 tablet carton
  • INGREDIENTS AND APPEARANCE
    NBB CITRUS 
    zinc gluconate, zinc oxide, and sambucus nigra flower tablet, orally disintegrating
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64762-870
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Zinc Gluconate (UNII: U6WSN5SQ1Z) (Zinc - UNII:J41CSQ7QDS) Zinc Gluconate1 [hp_X]
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide1 [hp_X]
    Sambucus Nigra Flower (UNII: 07V4DX094T) (Sambucus Nigra Flower - UNII:07V4DX094T) Sambucus Nigra Flower1 [hp_X]
    Product Characteristics
    ColorWHITEScoreno score
    ShapeROUNDSize6mm
    FlavorCITRUSImprint Code C
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64762-870-251 in 1 CARTON
    125 in 1 BOTTLE
    2NDC:64762-870-301 in 1 CARTON
    230 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Unapproved homeopathic11/04/2009
    Labeler - Dynamic Pharmaceuticals Inc. (617660712)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dynamic Pharmaceuticals Inc.617660712MANUFACTURE
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