SLEEPEASE- aquilegia, avena, chamomilla, coffea cruda, cypripedium, humulus, kali phos, passiflora, valeriana, zinc met liquid 
Eight & Company L.L.C

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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DRUG FACTS:

ACTIVE INGREDIENTS:

Aquilegia 4X, Avena 4X, Chamomilla 4X, Coffea cruda 200C, Cypripedium 4X, Humulus 4X, Kali phos 12X, Passiflora 4X, Valeriana 4X, Zinc met 12X.

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:

Contains alcohol, in case of overdose, get medical help or contact a Poison Control Center right away.

INDICATIONS:

Temporarily relieves the common symptoms of sleeplessness, including:

º wakefulness

º restlessness

º emotional stress and anxiety

º caffeine sensitivity

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 INFORMATION:

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

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

INACTIVE INGREDIENTS:

Non-GMO Glycerin, organic alcohol 20% v/v, purified water.

PACKAGE LABEL DISPLAY:

SleepEase LBL

NDC 61096-2001-1

sprayology

SleepEase

RELIEVES 

RESTLESSNESS

HOMEOPATHIC ORAL SPRAY

1.38 fl.oz (41 ml)

SleepEase LBL

SleepEase CNT

SLEEPEASE 
aquilegia, avena, chamomilla, coffea cruda, cypripedium, humulus, kali phos, passiflora, valeriana, zinc met liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61096-2001
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AQUILEGIA VULGARIS (UNII: 8POZ61U1G2) (AQUILEGIA VULGARIS - UNII:8POZ61U1G2) AQUILEGIA VULGARIS4 [hp_X]  in 41 mL
AVENA SATIVA FLOWERING TOP (UNII: MA9CQJ3F7F) (AVENA SATIVA FLOWERING TOP - UNII:MA9CQJ3F7F) AVENA SATIVA FLOWERING TOP4 [hp_X]  in 41 mL
MATRICARIA CHAMOMILLA WHOLE (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA WHOLE - UNII:G0R4UBI2ZZ) MATRICARIA CHAMOMILLA WHOLE4 [hp_X]  in 41 mL
ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72) ARABICA COFFEE BEAN200 [hp_C]  in 41 mL
CYPRIPEDIUM PARVIFLORUM VAR. PUBESCENS ROOT (UNII: 21Y9GZ1LZA) (CYPRIPEDIUM PARVIFLORUM VAR. PUBESCENS ROOT - UNII:21Y9GZ1LZA) CYPRIPEDIUM PARVIFLORUM VAR. PUBESCENS ROOT4 [hp_X]  in 41 mL
HOPS (UNII: 01G73H6H83) (HOPS - UNII:01G73H6H83) HOPS4 [hp_X]  in 41 mL
DIBASIC POTASSIUM PHOSPHATE (UNII: CI71S98N1Z) (PHOSPHATE ION - UNII:NK08V8K8HR) DIBASIC POTASSIUM PHOSPHATE12 [hp_X]  in 41 mL
PASSIFLORA INCARNATA FLOWERING TOP (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA FLOWERING TOP - UNII:CLF5YFS11O) PASSIFLORA INCARNATA FLOWERING TOP4 [hp_X]  in 41 mL
VALERIAN (UNII: JWF5YAW3QW) (VALERIAN - UNII:JWF5YAW3QW) VALERIAN4 [hp_X]  in 41 mL
ZINC (UNII: J41CSQ7QDS) (ZINC - UNII:J41CSQ7QDS) ZINC12 [hp_X]  in 41 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
ALCOHOL (UNII: 3K9958V90M)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61096-2001-11 in 1 CARTON04/24/2019
141 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic04/24/2019
Labeler - Eight & Company L.L.C (927364120)
Registrant - Apotheca Company (844330915)

Revised: 9/2023
Document Id: ae2f0ccf-6bd3-4eef-a393-97872b061b37
Set id: 9bd5fdc8-56b3-4e94-bd2f-1bfa9475c2e6
Version: 3
Effective Time: 20230918
 
Eight & Company L.L.C