SLEEPEASE- aquilegia, avena, chamomilla, coffea cruda, cypripedium, humulus, kali phos, passiflora, valeriana, zinc met liquid

SleepEase by

Drug Labeling and Warnings

SleepEase by is a Homeopathic medication manufactured, distributed, or labeled by Eight & Company L.L.C, King Bio Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient: Aquilegia 4X, Avena 4X, Chamomilla 4X, Coffea cruda 200C, Cypripedium 4X, Humulus 4X, Kali phos 12X, Passiflora 4X, Valeriana 4X, Zinc met 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.
• Children Under 12: 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: Non-GMO Glycerin, organic alcohol 20% v/v, 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

SLEEPEASE 
aquilegia, avena, chamomilla, coffea cruda, cypripedium, humulus, kali phos, passiflora, valeriana, zinc met liquid

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 61096-2001
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AQUILEGIA VULGARIS (UNII: 8POZ61U1G2) (AQUILEGIA VULGARIS - UNII:8POZ61U1G2)	AQUILEGIA VULGARIS	4 [hp_X]  in 41 mL
AVENA SATIVA FLOWERING TOP (UNII: MA9CQJ3F7F) (AVENA SATIVA FLOWERING TOP - UNII:MA9CQJ3F7F)	AVENA SATIVA FLOWERING TOP	4 [hp_X]  in 41 mL
MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ)	MATRICARIA RECUTITA	4 [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 PARVIFLORUM VAR. PUBESCENS ROOT (UNII: 21Y9GZ1LZA) (CYPRIPEDIUM PARVIFLORUM VAR. PUBESCENS ROOT - UNII:21Y9GZ1LZA)	CYPRIPEDIUM PARVIFLORUM VAR. PUBESCENS ROOT	4 [hp_X]  in 41 mL
HOPS (UNII: 01G73H6H83) (HOPS - UNII:01G73H6H83)	HOPS	4 [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	4 [hp_X]  in 41 mL
VALERIAN (UNII: JWF5YAW3QW) (VALERIAN - UNII:JWF5YAW3QW)	VALERIAN	4 [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: 61096-2001-1	1 in 1 CARTON	04/24/2019
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		04/24/2019

Labeler - Eight & Company L.L.C (927364120)

Registrant - Eight & Company L.L.C (927364120)