GUNA-ANTI IL 1 (ANTI-INTERLEUKIN-1.ALPHA. IMMUNOGLOBULIN G RABBIT- CANAKINUMAB) SOLUTION/ DROPS [GUNA SPA]

GUNA-ANTI IL 1 (ANTI-INTERLEUKIN-1.ALPHA. IMMUNOGLOBULIN G RABBIT- CANAKINUMAB) SOLUTION/ DROPS [GUNA SPA]
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NDC 17089-398-18
Set ID aee80c48-6271-48bb-baaa-31427fef1f26
Category HUMAN OTC DRUG LABEL
Packager Guna spa
Generic Name
Product Class
Product Number
Application Number
  • 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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