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

GUNA-AWARENESS by

Drug Labeling and Warnings

GUNA-AWARENESS by is a Homeopathic medication manufactured, distributed, or labeled by Guna spa. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 STIMULATES ADRENAL CORTEX

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

USES

Temporary relief of symptoms related to:

• Difficulty concentrating
• Difficulty falling asleep
• Irritability

WARNINGS

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

Keep out of reach of children

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

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

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	12/21/2018
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		04/16/2008

Labeler - Guna spa (430538264)

Establishment
Name	Address	ID/FEI	Business Operations
Guna spa		338587646	manufacture(17089-350)