Label: ZICAM COLD REMEDY RAPIDMELTS CITRUS- zinc acetate anhydrous and zinc gluconate tablet

  • NDC Code(s): 62750-044-10, 62750-044-11, 62750-044-12, 62750-044-14, view more
    62750-044-16
  • Packager: Matrixx Initiatives, Inc.
  • 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 April 27, 2020

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

  • 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
    • helps reduce severity of cold symptoms:
      • sore throat
      • stuffy nose
      • sneezing
      • coughing
      • nasal congestion

    Zicam® 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 a fever or new symptoms occur

    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 2–3 hours, not to exceed 7 tablets in 24 hours. Take 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: ask a doctor before use
  • Other information

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

    ascorbic acid, crospovidone, FD&C yellow no. 6 aluminum lake, magnesium stearate, mannitol, mono-ammonium glycyrrhizinate, natural and artificial flavor, sodium starch glycolate, stearic acid, sucralose

  • Questions? Comments? Side Effects?

    call 877-942-2626 toll free

  • SPL UNCLASSIFIED SECTION

    Distributed by Matrixx Initiatives, Inc.
    Scottsdale, Arizona 85260.

  • PRINCIPAL DISPLAY PANEL - 25 Tablet Bottle Carton

    CLINICALLY PROVEN TO SHORTEN COLDS

    GREAT
    TASTING!

    RAPIDMELTS®

    Citrus Flavor

    25
    Quick Dissolve
    TABLETS

    HOMEOPATHIC

    PRINCIPAL DISPLAY PANEL - 25 Tablet Bottle Carton
  • INGREDIENTS AND APPEARANCE
    ZICAM  COLD REMEDY RAPIDMELTS CITRUS
    zinc acetate anhydrous and zinc gluconate tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62750-044
    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 (15 MPA.S AT 5%) (UNII: 68401960MK)  
    FD&C Yellow No. 6 (UNII: H77VEI93A8)  
    aluminum oxide (UNII: LMI26O6933)  
    magnesium stearate (UNII: 70097M6I30)  
    mannitol (UNII: 3OWL53L36A)  
    ammonium glycyrrhizate (UNII: 3VRD35U26C)  
    stearic acid (UNII: 4ELV7Z65AP)  
    sucralose (UNII: 96K6UQ3ZD4)  
    sodium starch glycolate type A potato (UNII: 5856J3G2A2)  
    Product Characteristics
    ColorORANGE (Speckled) Scoreno score
    ShapeROUND (cup shaped) Size15mm
    FlavorCITRUSImprint Code Z
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62750-044-101 in 1 CARTON10/01/2011
    125 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC:62750-044-111 in 1 CARTON10/01/2011
    245 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    3NDC:62750-044-121 in 1 CARTON04/06/2016
    35 in 1 BLISTER PACK; Type 0: Not a Combination Product
    4NDC:62750-044-141 in 1 CARTON07/27/2018
    456 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    5NDC:62750-044-161 in 1 CARTON06/10/2019
    512 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED HOMEOPATHIC10/01/2011
    Labeler - Matrixx Initiatives, Inc. (790037253)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.833150803MANUFACTURE(62750-044)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305MANUFACTURE(62750-044) , PACK(62750-044)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.868734088MANUFACTURE(62750-044) , PACK(62750-044)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464MANUFACTURE(62750-044) , PACK(62750-044)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837MANUFACTURE(62750-044) , PACK(62750-044)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nutritional Labs International607917999REPACK(62750-044)