GUNA-DIUR (AMILORIDE - APIS MELLIFERA - BERBERIS VULGARIS FRUIT - HIERACIUM PILOSELLA FLOWERING TOP - HYDROCHLOROTHIAZIDE - SOLIDAGO VIRGAUREA FLOWERING TOP - SPIRONOLACTONE - SUS SCROFA PITU

GUNA-DIUR (AMILORIDE - APIS MELLIFERA - BERBERIS VULGARIS FRUIT - HIERACIUM PILOSELLA FLOWERING TOP - HYDROCHLOROTHIAZIDE - SOLIDAGO VIRGAUREA FLOWERING TOP - SPIRONOLACTONE - SUS SCROFA PITU
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NDC 17089-260-18
Set ID 3f91cd92-eb6d-4bda-9cad-2e11e0b0fbe2
Category HUMAN PRESCRIPTION DRUG LABEL
Packager Guna spa
Generic Name
Product Class
Product Number
Application Number
  • 1. INDICATIONS AND USAGE


    1.1 Temporary relief of fluid retention
    1.2 Tissue swelling and related disconforts




  • 2. DOSAGE AND ADMINISTRATION

    Adults: 20 drops in a little water, 2 times per day for an avarage of two months.

    Stop use and ask a doctor if symptoms persist more than 5 days.

    Administration may very according to individual needs.

    GUNA-DIUR may be used together with other homeopthic medicines.

  • 3. DOSAGE FORMS AND STRENGTHS

    3.1. 30 ml Bottle dropper container contains:
    Active ingredients: Amiloride 4X 0.006 ml, Apis Mellifica 2X 0.626 ml, Berberis Vulgaris T 0.314 ml, Hydrochlorothiazide 4X 0.006 ml, Hypophysis 12X 6.314 ml, Mouse-Ear Hawkweed T 6.314 ml, Solidago Virgaurea T 0.314 ml, Spironolactone 4X 0.006 ml.
    Inactive Ingredient: Ethylic Alcohol 30%


  • 4. CONTRAINDICATIONS

    4.1. There is no history of hypersensitivity to GUNA-DIUR. However, do not use if you are hypersensitive to any of the active ingredients of Guna-Diur.

  • 5. WARNINGS AND PRECAUTIONS

    5.1. GUNA-DIUR is contraindicated in patients with anuria and in patients with a history of hypersensitivity to Spironolactone, Amiloride, or Hydrocholorthiazide.

    5.2. Use with caution in patients taking diuretic medications.

    5.3 Keep out of reach of children.


  • 6. ADVERSE REACTIONS

    6.1.    None known (see CONTRAINDICATIONS for hypersensitivity information).

  • 7. DRUG INTERACTIONS

    7.1.    None Known

  • 8. USE IN SPECIFIC POPULATIONS

    8.1. Pregnancy: Pregnancy category C. Animal reproduction studies have not been conducted with GUNA-DIUR. GUNA®- DIUR should not be given to a pregnant woman.

    8.2. Lactation: It is not known whether any of the ingredients in GUNA- DIUR are secreted in human milk. However, since many drugs are secreted in human milk, caution should be exercised when GUNA- DIUR is administered to a nursing woman.

    8.3. Pediatric use: Safety and effectiveness in pediatric patients have not been established.


    8.4. Geriatric use: No restrictions.

  • 9. DRUG ABUSE AND DEPENDENCE

    9.1.    No Known.

  • 10. OVERDOSAGE

    10.1.    No Known.

  • 11. DESCRIPTION

    11. 1 GUNA-DIUR is a homeopathic medicine indicated for the temporary relief of fluid retention, tissue swelling and related disconforts.

  • 12. CLINICAL PHARMACOLOGY

    12.1. GUNA-DIUR exerts a diuretic effect. This is based on homeopthica Materia Medica and homeopathic principles.

    12.2. Pharmacodynamics
    Not applicable to homeopthic medicinal products.

    12.3. Pharmacokinetics

    Not applicable to homeopthic medicinal products.


  • 13. NONCLINICAL TOXICOLOGY

    13.1. Not available.


  • 14. CLINICAL STUDIES

    14.1. GUNA-DIUR efficacy is not supported by clinical studies. It is based on homeopathic Materia Medica and scientific literature.

  • 15. REFERENCES

    15.1.    H.H. Reckeweg. Homeopathic Materia Medica.  Aurelia Verlag.
    15.2.    Boericke,  William,  Materia  Medica  with  Reperatory,  1927,  ninth edition

  • 16. HOW SUPPLIED/STORAGE AND HANDLING

    16.1. NDC 17089-260-18 Oral Solution/Drops 30 mL

    16.2. Store at 20-25°C (68-77° F). Excursions permitted between 15°-30°C (59°-86°F).

  • 17. PATIENT COUNSELING INFORMATION

    17.1.    Patients should be informed about Homeopathy and the main differences with conventional clinical approaches.

  • PACKAGE LABEL

    5USPIL-GUNA-DIUR-rev05-10-18

  • INGREDIENTS AND APPEARANCE
    GUNA-DIUR 
    amiloride - apis mellifera - berberis vulgaris fruit - hieracium pilosella flowering top - hydrochlorothiazide - solidago virgaurea flowering top - spironolactone - sus scrofa pituitary gland - solution/ drops
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:17089-260
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AMILORIDE (UNII: 7DZO8EB0Z3) (AMILORIDE - UNII:7DZO8EB0Z3) AMILORIDE4 [hp_X]  in 30 mL
    APIS MELLIFERA (UNII: 7S82P3R43Z) (APIS MELLIFERA - UNII:7S82P3R43Z) APIS MELLIFERA2 [hp_X]  in 30 mL
    BERBERIS VULGARIS FRUIT (UNII: 6XEF22AHC3) (BERBERIS VULGARIS FRUIT - UNII:6XEF22AHC3) BERBERIS VULGARIS FRUIT0.3 g  in 30 mL
    HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH) HYDROCHLOROTHIAZIDE4 [hp_X]  in 30 mL
    SUS SCROFA PITUITARY GLAND (UNII: E8S87O660T) (SUS SCROFA PITUITARY GLAND - UNII:E8S87O660T) SUS SCROFA PITUITARY GLAND12 [hp_X]  in 30 mL
    HIERACIUM PILOSELLA FLOWERING TOP (UNII: 08A7Y81S1P) (HIERACIUM PILOSELLA FLOWERING TOP - UNII:08A7Y81S1P) HIERACIUM PILOSELLA FLOWERING TOP0.3 g  in 30 mL
    SOLIDAGO VIRGAUREA FLOWERING TOP (UNII: 5405K23S50) (SOLIDAGO VIRGAUREA FLOWERING TOP - UNII:5405K23S50) SOLIDAGO VIRGAUREA FLOWERING TOP0.3 g  in 30 mL
    SPIRONOLACTONE (UNII: 27O7W4T232) (SPIRONOLACTONE - UNII:27O7W4T232) SPIRONOLACTONE4 [hp_X]  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:17089-260-181 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 homeopathic05/23/2006
    Labeler - Guna spa (430538264)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guna spa338587646manufacture(17089-260)

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