Label: GUNA-IL 8- interleukin-8 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 December 21, 2018

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  • ACTIVE INGREDIENTS/PURPOSE

    INTERLEUKIN-8   4C   Excess mucous secretions, Antibacterial immune support

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  • USES

    USES: Excess mucous secretions, Antibacterial immune support.

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  • WARNINGS

    Stop use and ask doctor if symptoms worsen or persist more than 5 days

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  • PREGNANCY

    If pregnant or breast-feeding ask a doctor before use

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  • WARNINGS

    Keep this and all medicines out of reach of children

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  • DIRECTIONS

    Take 15 minutes before meals.

    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.


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  • QUESTIONS

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

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  • INACTIVE INGREDIENT

    Inactive ingredient: Ethyl alcohol 30%.

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  • INDICATIONS & USAGE

    Take 15 minutes before meals.

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  • PRINCIPAL DISPLAY PANEL
  • INGREDIENTS AND APPEARANCE
    GUNA-IL 8 
    interleukin-8 solution/ drops
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:17089-386
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    INTERLEUKIN-8 (UNII: PC30892LX5) (INTERLEUKIN-8 - UNII:PC30892LX5) INTERLEUKIN-8 4 [hp_C]  in 30 mL
    Inactive Ingredients
    Ingredient Name Strength
    ALCOHOL (UNII: 3K9958V90M) 9 mL  in 30 mL
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:17089-386-18 1 in 1 BOX 01/11/2015 02/28/2021
    1 30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved homeopathic 06/17/2008 02/28/2021
    Labeler - Guna spa (430538264)
    Establishment
    Name Address ID/FEI Business Operations
    Guna spa 338587646 manufacture(17089-386)
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