GUNA SLEEP SUPPORT- avena sativa flowering top - caffeine - matricaria chamomilla whole - passiflora incarnata flowering top -potassium bromide - zinc valerate dihydrate - silver nitrate - strychnos ingatii seed - solution/ drops

GUNA SLEEP SUPPORT by

Drug Labeling and Warnings

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

Drug Details [pdf]

Uses:

• Helps to relax and fall asleep,
• Helps to stay asleep during the night

INDICATIONS & USAGE

Take 15 minutes before meals.

INACTIVE INGREDIENT

inactive ingredient: Ethyl alcohol 30%.

QUESTIONS

Questions?: info@gunainc.com

Tel. (484) 223-3500

DOSAGE & ADMINISTRATION

Adults and children 12 years and older: 20 drops in a little water, 2 times per day



Children between 12 and 6 years of age: 10 drops in a little water, 2 times per day



Children under 6 years: consulta a physician

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding ask a health care professional before use

WARNINGS

• Stop use and ask doctor if symptoms persist more than 5 days.
• If pregnant or breast-feeding ask a health care professional before use.
• Keep out of reach of children. In case of overdose, get professional assistance or contact a Poison Control Center immediately.
• Contains ethyl alcohol 30%

active ingredient/purpose

Avena sativa 2X Helps relaxation, helps sleep

Chamomilla 2X Helps relaxation, helps sleep

Caffeinum 6X Helps relaxation

Ignatia amara 4X Relieves nervousness

Kali bromatum 4X Helps sleep

Passiflora incarnata 2X Supports nighttime sleep

Zincum valerianicum 4X Supports nighttime sleep

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

GUNA SLEEP SUPPORT 
avena sativa flowering top - caffeine - matricaria chamomilla whole - passiflora incarnata flowering top -potassium bromide - zinc valerate dihydrate - silver nitrate - strychnos ingatii seed - solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 17089-471
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POTASSIUM BROMIDE (UNII: OSD78555ZM) (BROMIDE ION - UNII:952902IX06)	POTASSIUM BROMIDE	4 [hp_X]  in 30 mL
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E)	CAFFEINE	6 [hp_X]  in 30 mL
AVENA SATIVA FLOWERING TOP (UNII: MA9CQJ3F7F) (AVENA SATIVA FLOWERING TOP - UNII:MA9CQJ3F7F)	AVENA SATIVA FLOWERING TOP	2 [hp_X]  in 30 mL
MATRICARIA CHAMOMILLA WHOLE (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA WHOLE - UNII:G0R4UBI2ZZ)	MATRICARIA CHAMOMILLA WHOLE	2 [hp_X]  in 30 mL
STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (STRYCHNOS IGNATII SEED - UNII:1NM3M2487K)	STRYCHNOS IGNATII SEED	4 [hp_X]  in 30 mL
PASSIFLORA INCARNATA FLOWERING TOP (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA FLOWERING TOP - UNII:CLF5YFS11O)	PASSIFLORA INCARNATA FLOWERING TOP	2 [hp_X]  in 30 mL
SILVER NITRATE (UNII: 95IT3W8JZE) (SILVER CATION - UNII:57N7B0K90A)	SILVER NITRATE	30 [hp_X]  in 30 mL
ZINC VALERATE DIHYDRATE (UNII: MN0RX54EQA) (VALERIC ACID - UNII:GZK92PJM7B)	ZINC VALERATE DIHYDRATE	4 [hp_X]  in 30 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 17089-471-18	1 in 1 BOX	01/17/2021
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		01/17/2021

Labeler - Guna spa (430538264)

Establishment
Name	Address	ID/FEI	Business Operations
Guna spa		338587646	manufacture(17089-471)