Label: GUNA-AWARENESS - betaine - bufo bufo cutaneous gland - calcium carbonate - chromic sulfate - cicuta virosa root - copper - folic acid - gold - cobalamin - iron - lachesis muta venom - melatonin - molybdenum - neurotrophin-3 - neurotrophin-4 - oxytocin - silicon dioxide - sus scrofa frontal lobe - sus scrofa temporal lobe - thyrotropin alfa - ubidecarenone - vanadium - zinc - brain-derived neurotrophic factor human - 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 April 30, 2010

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  • ACTIVE INGREDIENTS/PURPOSE

    AURUM METALLICUM                                    12X    ANTIDEPRESSANT
    BRAIN DERIVED NEUROTROPHIC FACTOR     4C    HELPS MENTAL ACTIVITY
    BUFO RANA                                                    12X    HELPS MENTAL ACTIVITY
    CALCAREA CARBONICA                                3X    IMMUNE STRENGTHENING
    CHROMIUM SULPHURICUM                            3X    DETOXIFICATION
    CICUTA VIROSA                                            12X    ANTISPASTIC
    COBALAMIN                                                    3X    ANTIOXIDANT
    COENZYME Q                                                3X    ANTIOXIDANT
    CUPRUM METALLICUM                                12X    ANTISPASTIC
    FERRUM METALLICUM                                3X    ANTIOXIDANT
    FOLIC ACID                                                  3X    ANTIOXIDANT
    FRONTAL LOBE                                        6X    SUPPORTS COORDINATING BEHAVIOR
    LACHESIS MUTUS                                    12X    ANTI-INFLAMMATORY
    MELATONIN                                             4C    ANTISTRESS
    MOLYBDENUM METALLICUM                   3X    ANTIAGING
    NEUROTROPHIN 3                                    4C    SUPPORTS MENTAL ACTIVITY
    NEUROTROPHIN 4                                    4C    SUPPORTS MENTAL ACTIVITY
    OXYTOCIN                                                6X    ANTISPASTIC
    SILICEA                                                    12X    IMMUNE STRENGTHENING
    TEMPORAL LOBE                                        6X    SUPPORTS AUDITORY PROCESSING
    THYROTROPIN-RELEASING HORMONE        3X    HELPS MENTAL ACTIVITY
    TRIMETHYLGLYCINE                                3X    DETOXIFICATION
    VANADIUM METALLICUM                        6X    ANTIOXIDANT
    ZINCUM METALLICUM                            3X    ANTISTRESS


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  • USES

    For the temporary relief of symptoms of Impaired Cognitive Function such as: Inability to Concentrate, Restlessness, Easy distractibility

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  • WARNINGS

    Stop use and ask doctor if symptoms of  Inability to Concentrate, Restlessness, Easy distractibility  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 in a little water, 2 times per day
    Children  between 12 years and 6 years of age    10 drops in a little water, 2 times per day
    Children under 6 years     5 drops in a glass of water, 2 times per day

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  • QUESTIONS

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

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  • PRINCIPAL DISPLAY PANEL
  • INGREDIENTS AND APPEARANCE
    GUNA-AWARENESS 
    betaine - bufo bufo cutaneous gland - calcium carbonate - chromic sulfate - cicuta virosa root - copper - folic acid - gold - cobalamin - iron - lachesis muta venom - melatonin - molybdenum - neurotrophin-3 - neurotrophin-4 - oxytocin - silicon dioxide - sus scrofa frontal lobe - sus scrofa temporal lobe - thyrotropin alfa - ubidecarenone - vanadium - zinc - brain-derived neurotrophic factor human - solution/ drops
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:17089-350
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    GOLD (UNII: 79Y1949PYO) (GOLD - UNII:79Y1949PYO) GOLD 12 [hp_X]  in 30 mL
    BRAIN-DERIVED NEUROTROPHIC FACTOR HUMAN (UNII: 7171WSG8A2) (BRAIN-DERIVED NEUROTROPHIC FACTOR HUMAN - UNII:7171WSG8A2) BRAIN-DERIVED NEUROTROPHIC FACTOR HUMAN 4 [hp_C]  in 30 mL
    BUFO BUFO CUTANEOUS GLAND (UNII: Q59QU6N72Q) (BUFO BUFO CUTANEOUS GLAND - UNII:Q59QU6N72Q) BUFO BUFO CUTANEOUS GLAND 12 [hp_X]  in 30 mL
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CARBONATE 3 [hp_X]  in 30 mL
    CHROMIC SULFATE (UNII: Y0C99N5TMZ) (CHROMIC CATION - UNII:X1N4508KF1) CHROMIC SULFATE 3 [hp_X]  in 30 mL
    CICUTA VIROSA ROOT (UNII: YEA9P21S8N) (CICUTA VIROSA ROOT - UNII:YEA9P21S8N) CICUTA VIROSA ROOT 12 [hp_X]  in 30 mL
    COBALAMIN (UNII: 8406EY2OQA) (COBALAMIN - UNII:8406EY2OQA) COBALAMIN 3 [hp_X]  in 30 mL
    UBIDECARENONE (UNII: EJ27X76M46) (UBIDECARENONE - UNII:EJ27X76M46) UBIDECARENONE 3 [hp_X]  in 30 mL
    COPPER (UNII: 789U1901C5) (COPPER - UNII:789U1901C5) COPPER 12 [hp_X]  in 30 mL
    IRON (UNII: E1UOL152H7) (IRON - UNII:E1UOL152H7) IRON 3 [hp_X]  in 30 mL
    FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID 3 [hp_X]  in 30 mL
    SUS SCROFA FRONTAL LOBE (UNII: GV54Q19G55) (SUS SCROFA FRONTAL LOBE - UNII:GV54Q19G55) SUS SCROFA FRONTAL LOBE 6 [hp_X]  in 30 mL
    LACHESIS MUTA VENOM (UNII: VSW71SS07I) (LACHESIS MUTA VENOM - UNII:VSW71SS07I) LACHESIS MUTA VENOM 12 [hp_X]  in 30 mL
    MELATONIN (UNII: JL5DK93RCL) (MELATONIN - UNII:JL5DK93RCL) MELATONIN 4 [hp_C]  in 30 mL
    MOLYBDENUM (UNII: 81AH48963U) (MOLYBDENUM - UNII:81AH48963U) MOLYBDENUM 3 [hp_X]  in 30 mL
    NEUROTROPHIN-3 (UNII: 02R4V6T25Y) (NEUROTROPHIN-3 - UNII:02R4V6T25Y) NEUROTROPHIN-3 4 [hp_C]  in 30 mL
    NEUROTROPHIN-4 (UNII: P658DCA9XD) (NEUROTROPHIN-4 - UNII:P658DCA9XD) NEUROTROPHIN-4 4 [hp_C]  in 30 mL
    OXYTOCIN (UNII: 1JQS135EYN) (OXYTOCIN - UNII:1JQS135EYN) OXYTOCIN 6 [hp_X]  in 30 mL
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE 12 [hp_X]  in 30 mL
    SUS SCROFA TEMPORAL LOBE (UNII: 490XI1KB4S) (SUS SCROFA TEMPORAL LOBE - UNII:490XI1KB4S) SUS SCROFA TEMPORAL LOBE 6 [hp_X]  in 30 mL
    THYROTROPIN ALFA (UNII: AVX3D5A4LM) (THYROTROPIN ALFA - UNII:AVX3D5A4LM) THYROTROPIN ALFA 3 [hp_X]  in 30 mL
    BETAINE (UNII: 3SCV180C9W) (BETAINE - UNII:3SCV180C9W) BETAINE 3 [hp_X]  in 30 mL
    VANADIUM (UNII: 00J9J9XKDE) (VANADIUM - UNII:00J9J9XKDE) VANADIUM 6 [hp_X]  in 30 mL
    ZINC (UNII: J41CSQ7QDS) (ZINC - UNII:J41CSQ7QDS) ZINC 3 [hp_X]  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:17089-350-18 1 in 1 BOX
    1 30 mL in 1 BOTTLE, DROPPER
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved homeopathic 04/16/2008
    Labeler - Guna spa (430538264)
    Establishment
    Name Address ID/FEI Business Operations
    Guna spa 430538264 manufacture
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