SPRAYOLOGY SLEEPEASE- aquilegia vulgaris, avena sativa, chamomilla, coffea cruda, cypripedium pubescens, humulus lupulus, kali phosphoricum, passiflora incarnata, valeriana officinalis, zincum metallicum liquid

Sprayology SleepEase by

Drug Labeling and Warnings

Sprayology SleepEase by is a Homeopathic medication manufactured, distributed, or labeled by Eight and Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient: Aquilegia vulgaris 2X, Avena sativa 2X, Chamomilla 2X, Coffea cruda 200C, Cypripedium pubescens 3X, Humulus lupulus 3X, Kali phosphoricum 12X, Passiflora incarnata 2X, Valeriana officinalis 2X, Zincum metallicum 12X.

WARNINGS

Warnings: If sleeplessness persists continuously for more than 2 weeks, consult your doctor. Insomnia may be a symptom of serious underlying medical illness. If pregnant or breast-feeding, ask a health care professional before use. Keep out of reach of children. Contains alcohol, in case of overdose, get medical help or contact a Poison Control Center right away.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

INDICATIONS & USAGE

Temporarily relieves the common symptoms of sleeplessness, including:

• wakefulness
• restlessness
• emotional stress and anxiety
• caffeine sensitivity

DOSAGE & ADMINISTRATION

Directions:

• Adults and children over 12: 2 sprays into the mouth at bedtime and if sleep is interrupted.
• Ages 2 to 12: 1 spray into the mouth at bedtime and if sleep is interrupted.
• Under age 2: consult a health care professional.

OTHER SAFETY INFORMATION

Other Information: Do not use if the transparent seal around spray bottle is broken or missing.

INACTIVE INGREDIENT

Inactive Ingredients: Glycerin 10%, v/v, non-GMO organic alcohol 9% v/v and purified water.

PURPOSE

Temporarily relieves the common symptoms of sleeplessness, including:

° wakefulness

° restlessness

° emotional stress and anxiety

° caffeine sensitivity

° natural

° gluten free

° no artifical flavors or colors

° vegan

° no known negative side effects

° no known negative drug interactions

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SPRAYOLOGY SLEEPEASE 
aquilegia vulgaris, avena sativa, chamomilla, coffea cruda, cypripedium pubescens, humulus lupulus, kali phosphoricum, passiflora incarnata, valeriana officinalis, zincum metallicum liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61096-1001
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AQUILEGIA VULGARIS (UNII: 8POZ61U1G2) (AQUILEGIA VULGARIS - UNII:8POZ61U1G2)	AQUILEGIA VULGARIS	2 [hp_X]  in 41 mL
AVENA SATIVA FLOWERING TOP (UNII: MA9CQJ3F7F) (AVENA SATIVA FLOWERING TOP - UNII:MA9CQJ3F7F)	AVENA SATIVA FLOWERING TOP	2 [hp_X]  in 41 mL
MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ)	MATRICARIA RECUTITA	2 [hp_X]  in 41 mL
ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72)	ARABICA COFFEE BEAN	200 [hp_C]  in 41 mL
CYPRIPEDIUM PARVIFOLUM ROOT (UNII: 21Y9GZ1LZA) (CYPRIPEDIUM PARVIFOLUM ROOT - UNII:21Y9GZ1LZA)	CYPRIPEDIUM PARVIFOLUM ROOT	3 [hp_X]  in 41 mL
HOPS (UNII: 01G73H6H83) (HOPS - UNII:01G73H6H83)	HOPS	3 [hp_X]  in 41 mL
POTASSIUM PHOSPHATE, DIBASIC (UNII: CI71S98N1Z) (PHOSPHATE ION - UNII:NK08V8K8HR)	POTASSIUM PHOSPHATE, DIBASIC	12 [hp_X]  in 41 mL
PASSIFLORA INCARNATA FLOWERING TOP (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA FLOWERING TOP - UNII:CLF5YFS11O)	PASSIFLORA INCARNATA FLOWERING TOP	2 [hp_X]  in 41 mL
VALERIAN (UNII: JWF5YAW3QW) (VALERIAN - UNII:JWF5YAW3QW)	VALERIAN	2 [hp_X]  in 41 mL
ZINC (UNII: J41CSQ7QDS) (ZINC - UNII:J41CSQ7QDS)	ZINC	12 [hp_X]  in 41 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
ALCOHOL (UNII: 3K9958V90M)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61096-1001-2	1 in 1 CARTON	07/28/2016
1		41 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		07/28/2016

Labeler - Eight and Company (927364120)

Registrant - Eight and Company (927364120)