Label: GUNA-ANTI IL 1- anti-interleukin-1.alpha. immunoglobulin g rabbit- canakinumab solution/ drops

  • 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 November 15, 2022

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  • ACTIVE INGREDIENTS/PURPOSE

    ANTI INTERLEUKIN 1 ALPHA      4C    ACUTE PAIN AND FEVER RELIEF
    ANTI INTERLEUKIN 1 BETA        4C     ACUTE PAIN AND FEVER RELIEF

  • USES

    Temporary relief of:

    • Acute pain
    • Fever
  • WARNINGS

    • Stop use and ask doctor if symptoms persist more than 5 days.
    • 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.
    • Contains ethyl alcohol 30%

  • PREGNANCY

    If pregnant or breast-feeding ask a doctor before use.

  • WARNINGS

    Keepout of reach of children.

  • DIRECTIONS

    Adults and children 12 years and older 20 drops twice a day in a little water. Hold in the mouth for about 30 seconds then swallow.

    Children between 12 years and 6 years of age 10 drops twice a day in a little water. Hold in the mouth for about 30 seconds then swallow.

    Children under 6 years 5 drops twice a day in a glass of water.


  • QUESTIONS

    Questions?: info@gunainc.com
    Tel. (484) 223-3500

  • INDICATIONS & USAGE

    Take 15 minutes before meals.

  • INACTIVE INGREDIENT

    Inactive ingredient: Ethyl alcohol 30%.

  • PRINCIPAL DISPLAY PANEL

    5U1AI1-Guna-Anti_IL_1-Rev2-100718

  • INGREDIENTS AND APPEARANCE
    GUNA-ANTI IL 1 
    anti-interleukin-1.alpha. immunoglobulin g rabbit- canakinumab solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:17089-398
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ANTI-INTERLEUKIN-1.ALPHA. IMMUNOGLOBULIN G RABBIT (UNII: ML4QRZ1HCL) (ANTI-INTERLEUKIN-1.ALPHA. IMMUNOGLOBULIN G RABBIT - UNII:ML4QRZ1HCL) ANTI-INTERLEUKIN-1.ALPHA. IMMUNOGLOBULIN G RABBIT4 [hp_C]  in 30 mL
    CANAKINUMAB (UNII: 37CQ2C7X93) (CANAKINUMAB - UNII:37CQ2C7X93) CANAKINUMAB4 [hp_C]  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M) 9 mL  in 30 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:17089-398-181 in 1 BOX12/21/2018
    130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic06/17/2008
    Labeler - Guna spa (430538264)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guna spa338587646manufacture(17089-398)
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