Label: GUNA-DIUR- amiloride - apis mellifera - berberis vulgaris fruit - hieracium pilosella flowering top - hydrochlorothiazide - solidago virgaurea flowering top - spironolactone - sus scrofa pituitary gland - solution/ drops

  • Category: HUMAN PRESCRIPTION DRUG LABEL

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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  • 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)