GUNA-SLEEP- avena sativa flowering top - canakinumab - chamomile - helleborus niger root - melatonin - melissa officinalis - pulsatilla vulgaris - serotonin - strychnos ignatii seed - sus scrofa pineal gland - valerian - solution/ drops

GUNA-SLEEP by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT

Avena sativa 6C Nervousness

Chamomilla 6C Restlessness

Helleborus niger 6C Mental stress

Ignatia amara 6C Restlessness

Interleukin 1 beta 4C Immune support

Melatonin 4C Hormonal regulation

Melissa officinalis 6C Anxiety

Pineal gland 6X 12X 30X Hormonal regulation

Pulsatilla 6C Mood support

Serotonin 6C Hormonal support

Valeriana officinalis 6C Restlessness

PURPOSE

Temporary relief of:

• Difficulty falling asleep
  

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 OR BREAST FEEDING

If pregnant or breast-feeding ask a doctor before use

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

DOSAGE & ADMINISTRATION

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

INACTIVE INGREDIENT

inactive ingredient: Ethyl alcohol 30%.

INDICATIONS & USAGE

Take 15 minutes before meals.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

GUNA-SLEEP 
avena sativa flowering top - canakinumab - chamomile - helleborus niger root - melatonin - melissa officinalis - pulsatilla vulgaris - serotonin - strychnos ignatii seed - sus scrofa pineal gland - valerian - solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 17089-294
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVENA SATIVA FLOWERING TOP (UNII: MA9CQJ3F7F) (AVENA SATIVA FLOWERING TOP - UNII:MA9CQJ3F7F)	AVENA SATIVA FLOWERING TOP	6 [hp_C]  in 30 mL
CHAMOMILE (UNII: FGL3685T2X) (CHAMOMILE - UNII:FGL3685T2X)	CHAMOMILE	6 [hp_C]  in 30 mL
HELLEBORUS NIGER ROOT (UNII: 608DGJ6815) (HELLEBORUS NIGER ROOT - UNII:608DGJ6815)	HELLEBORUS NIGER ROOT	6 [hp_C]  in 30 mL
STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (STRYCHNOS IGNATII SEED - UNII:1NM3M2487K)	STRYCHNOS IGNATII SEED	6 [hp_C]  in 30 mL
CANAKINUMAB (UNII: 37CQ2C7X93) (CANAKINUMAB - UNII:37CQ2C7X93)	CANAKINUMAB	4 [hp_C]  in 30 mL
MELATONIN (UNII: JL5DK93RCL) (MELATONIN - UNII:JL5DK93RCL)	MELATONIN	4 [hp_C]  in 30 mL
MELISSA OFFICINALIS (UNII: YF70189L0N) (MELISSA OFFICINALIS - UNII:YF70189L0N)	MELISSA OFFICINALIS	6 [hp_C]  in 30 mL
SUS SCROFA PINEAL GLAND (UNII: 050QZ2EDK7) (SUS SCROFA PINEAL GLAND - UNII:050QZ2EDK7)	SUS SCROFA PINEAL GLAND	12 [hp_X]  in 30 mL
PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV)	PULSATILLA VULGARIS	6 [hp_C]  in 30 mL
SEROTONIN (UNII: 333DO1RDJY) (SEROTONIN - UNII:333DO1RDJY)	SEROTONIN	6 [hp_C]  in 30 mL
VALERIAN (UNII: JWF5YAW3QW) (VALERIAN - UNII:JWF5YAW3QW)	VALERIAN	6 [hp_C]  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 17089-294-18	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		05/23/2006

Labeler - Guna spa (430538264)

Establishment
Name	Address	ID/FEI	Business Operations
Guna spa		338587646	manufacture(17089-294)