Label: ULTRA COLD REMEDY RAPIDMELTS- zinc acetate 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 February 5, 2015

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients (in each tablet)

    Zincum aceticum 2x
    Zincum gluconicum 1x

  • Purpose

    Reduces duration and severity of the common cold

  • Uses

    • reduces duration of the common cold
    • reduces the severity of cold symptoms:
      • sore throat
      • stuffy nose
      • sneezing
      • coughing
      • nasal congestion

    Zicam® ULTRA Cold Remedy was formulated to shorten the duration of the common cold 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 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 Control Center right away.

  • 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 4-6 hours, not to exceed 4 tablets in 24 hours
      • 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: ask a doctor before use
  • Other information

    • store between 15-29° (59-84°F)
  • Inactive ingredients

    artificial flavor, crospovidone, FD&C red no. 40 aluminum lake, magnesium stearate, mannitol, monoammonium glycyrrhizinate, sodium starch glycolate, stearic acid, sucralose

  • Questions/Comments

    Questions/Comments call 1-844-287-0260

  • SPL UNCLASSIFIED SECTION

    Manufactured by Izeen Pharma, Inc. 6900 English Muffin Way, Unit A, Frederick, MD 21703

  • PRINCIPAL DISPLAY PANEL - 18 Tablet Carton

    NDC# 66007-103-18

    Principal Display Panel-Carton

  • INGREDIENTS AND APPEARANCE
    ULTRA COLD REMEDY RAPIDMELTS 
    zinc acetate and zinc gluconate tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66007-103
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC ACETATE (UNII: FM5526K07A) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION2 [hp_X]
    ZINC GLUCONATE (UNII: U6WSN5SQ1Z) (ZINC CATION - UNII:13S1S8SF37) ZINC GLUCONATE1 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    CROSPOVIDONE (UNII: 68401960MK)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MANNITOL (UNII: 3OWL53L36A)  
    AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    ColorPINKScoreno score
    ShapeROUNDSize15mm
    FlavorCHERRYImprint Code Z
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66007-103-181 in 1 CARTON
    118 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Unapproved homeopathic02/06/2015
    Labeler - Izeen Pharma, Inc. (079300974)
    Establishment
    NameAddressID/FEIBusiness Operations
    Izeen Pharma, Inc.079300974MANUFACTURE(66007-103)
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