GUNA-MALE- adenosinum ciclophosphoricum - melatonin - phosphorus - sus scrofa adrenal gland - sus scrofa hypothalamus - sus scrofa pancreas - sus scrofa pineal gland - sus scrofa pituitary gland - sus scrofa testicle - sus scrofa thymus - thyroid - turnera diffusa top - solution/ drops
Guna spa

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.

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GUNA-MALE

ACTIVE INGREDIENTS/PURPOSE

ADENOSINUM CYCLOPHOSPHORICUM 6X HORMONAL REGULATION

DAMIANA 6X 12X 30X HORMONAL REGULATION

GLANDULA SUPRARENALIS 6X 12X 30X 200X HORMONAL REGULATION

HYPOPHYSIS 6X 12X 30X 200X HORMONAL REGULATION

HYPOTHALAMUS 6X 12X 30X 200X HORMONAL REGULATION

MELATONIN 6X 12X 30X 200X HORMONAL REGULATION

ORCHITINUM 6X 12X 30X 200X DETOXIFICATION

PANCREAS 6X, 12X, 30X, 200X HORMONAL REGULATION

PHOSPHORUS 6X REDUCES EXHAUSTION

PINEAL GLAND 6X 12X 30X 200X HORMONAL REGULATION

THYMUS GLAND 6X 12X 30X 200X HORMONAL REGULATION

THYROIDINUM 6X 12X 30X 200X HORMONAL REGULATION

USES

Temporary relief of symptoms due to hormonal imbalances, such as:

Mood Fluctuations
Irritability
Sleep disturbance

WARNINGS

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

Children under 9 years Ask your doctor.

QUESTIONS

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

Take 15 minutes before meals.

Inactive ingredient: Ethyl alcohol 30%.

PRINCIPAL DISPLAY PANEL

5USK2M-Rev06-25-05-18

GUNA-MALE
adenosinum ciclophosphoricum - melatonin - phosphorus - sus scrofa adrenal gland - sus scrofa hypothalamus - sus scrofa pancreas - sus scrofa pineal gland - sus scrofa pituitary gland - sus scrofa testicle - sus scrofa thymus - thyroid - turnera diffusa top - solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:17089-233
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ADENOSINE CYCLIC PHOSPHATE (UNII: E0399OZS9N) (ADENOSINE CYCLIC PHOSPHATE - UNII:E0399OZS9N)	ADENOSINE CYCLIC PHOSPHATE	6 [hp_X] in 30 mL
TURNERA DIFFUSA LEAFY TWIG (UNII: RQ2CFA7WWJ) (TURNERA DIFFUSA LEAFY TWIG - UNII:RQ2CFA7WWJ)	TURNERA DIFFUSA LEAFY TWIG	6 [hp_X] in 30 mL
SUS SCROFA ADRENAL GLAND (UNII: 398IYQ16YV) (SUS SCROFA ADRENAL GLAND - UNII:398IYQ16YV)	SUS SCROFA ADRENAL GLAND	30 [hp_X] in 30 mL
SUS SCROFA PITUITARY GLAND (UNII: E8S87O660T) (SUS SCROFA PITUITARY GLAND - UNII:E8S87O660T)	SUS SCROFA PITUITARY GLAND	30 [hp_X] in 30 mL
SUS SCROFA HYPOTHALAMUS (UNII: N6R0856Z79) (SUS SCROFA HYPOTHALAMUS - UNII:N6R0856Z79)	SUS SCROFA HYPOTHALAMUS	30 [hp_X] in 30 mL
MELATONIN (UNII: JL5DK93RCL) (MELATONIN - UNII:JL5DK93RCL)	MELATONIN	30 [hp_X] in 30 mL
SUS SCROFA TESTICLE (UNII: KM02613O28) (SUS SCROFA TESTICLE - UNII:KM02613O28)	SUS SCROFA TESTICLE	30 [hp_X] in 30 mL
SUS SCROFA PANCREAS (UNII: 9Y3J3362RY) (SUS SCROFA PANCREAS - UNII:9Y3J3362RY)	SUS SCROFA PANCREAS	30 [hp_X] in 30 mL
PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W)	PHOSPHORUS	6 [hp_X] in 30 mL
SUS SCROFA PINEAL GLAND (UNII: 050QZ2EDK7) (SUS SCROFA PINEAL GLAND - UNII:050QZ2EDK7)	SUS SCROFA PINEAL GLAND	30 [hp_X] in 30 mL
SUS SCROFA THYMUS (UNII: 7B69B0BD62) (SUS SCROFA THYMUS - UNII:7B69B0BD62)	SUS SCROFA THYMUS	30 [hp_X] in 30 mL
THYROID (UNII: 0B4FDL9I6P) (THYROID - UNII:0B4FDL9I6P)	THYROID	30 [hp_X] in 30 mL

Ingredient Name	Strength
Inactive Ingredients
ALCOHOL (UNII: 3K9958V90M)	9 mL in 30 mL

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:17089-233-18	1 in 1 BOX	12/21/2018
1		30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		05/23/2006

Labeler - Guna spa (430538264)

Name	Address	ID/FEI	Business Operations
Establishment
Guna spa		338587646	manufacture(17089-233)