Label: COLD-FIX (FOR CHILDREN)- affinity purified antibodies to human gamma interferon tablet

  • NDC Code(s): 71344-003-01, 71344-003-02
  • Packager: Seme USA 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 December 30, 2020

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

  • ACTIVE INGREDIENT

    Affinity purified antibodies to human gamma interferon mixture of

    Homeopathic dilution, C12

    Homeopathic dilution, C30

    Homeopathic dilution, C200

  • PURPOSE

    To reduce severity and duration of cold and flu symptoms including nasal congestion, cough, and fever

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

  • INDICATIONS & USAGE

    • Shortens the durations of cold and flu symptoms
    • Offers temporary relief of cold and flu symptoms including nasal congestion, cough and fever
  • WARNINGS

    Warnings

    • Keep out reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
    • Ask a doctor or pharmacist before use if your child is under 6 months of age
    • Stop use and ask a doctor if symptoms persist more than 4 days
  • DOSAGE & ADMINISTRATION

    For Treatment

    • On day 1 of treatment: within the first 2 hours - take a tablet every 30 minutes ( a total of 5 tablets).
    • Next 3 doses should be taken at equal intervals (a total of 8 administrations in the first day)
    • Should be taken 3 times daily approximately every 8 hours at equal intervals over days 2 to 7. The overall duration of treatment is 5 to 7 days.
    • The tablet should be held in the mouth until completely dissolved. Do not take with a meal. No other restrictions apply. For children from 6 to 36 months of age, it is recommended to completely dissolve a tablet in a tablespoon of drinking water.

    For prophylaxis

    • Should be taken once daily for 1 to 3 months around cold and flu season
  • INACTIVE INGREDIENT

    Lactose monohydrate, Magnesium Stearate, Microcrystalline cellulose

  • OTHER SAFETY INFORMATION

    • Cold-Fix contains lactose monohydrate. Individuals who are lactose-intolerant should take precaution when taking this product.
    • Store in original package below 30°C or 86°F.
    • Do not use if blister pack is torn or broken
  • PRINCIPAL DISPLAY PANEL

    20 tabs

    40 tabs

  • INGREDIENTS AND APPEARANCE
    COLD-FIX (FOR CHILDREN) 
    affinity purified antibodies to human gamma interferon tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71344-003
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    INTERFERON-.GAMMA. (UNII: P050J5FWC5) (INTERFERON-.GAMMA. - UNII:P050J5FWC5) INTERFERON-.GAMMA.12 [hp_C]
    Inactive Ingredients
    Ingredient NameStrength
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    Product Characteristics
    ColorwhiteScore2 pieces
    ShapeROUND (circular) Size9mm
    FlavorImprint Code COLDFIX
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71344-003-022 in 1 PACKET03/27/2017
    1NDC:71344-003-0120 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic03/27/2017
    Labeler - Seme USA Inc (080579137)
    Establishment
    NameAddressID/FEIBusiness Operations
    Santonika Uab520214047manufacture(71344-003)