SERENE SLEEP (eschscholtzia californica, chamomilla, cina, coffea cruda, nux vomica, passiflora incarnata, pulsatilla- pratensis, ignatia amara, kali phosphoricum, rhus tox spray

Serene Sleep by

Drug Labeling and Warnings

Serene Sleep by is a Homeopathic medication manufactured, distributed, or labeled by The Wellness Center for Research a, Apotheca Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS:

Eschscholtzia Californica 3C, Chamomilla 3C, 6C, 30C, Cina 6C, 30C, Coffea Cruda 6C, 30C, Nux Vomica 6C, 30C, Passiflora Incarnata 6C, 30C, Pulsatilla (Pratensis) 6C, 30C, Ignatia Amara 30C, Kali Phosphoricum 30C, Rhus Tox 30C.

INDICATIONS:

Supports a reduction in stress-related sleep issues, nightmares, waking during the early morning hours. Temporary relief of nervousness, anxiety, restlessness. overactive mind, mood disorders, grief, muscular discomfort.

WARNINGS:

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.

Do not use if seal is broken or missing.

KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

DIRECTIONS:

Spray orally, 4 to 6 sprays, at least 30 minutes before bed and 30 minutes after eating. Consult a physician for use in children under 12 years of age.

INDICATIONS:

Supports a reduction in stress-related sleep issues, nightmares, waking during the early morning hours. Temporary relief of nervousness, anxiety, restlessness. overactive mind, mood disorders, grief, muscular discomfort.

INACTIVE INGREDIENTS:

Demineralized Water, 25% Organic Ethanol

QUESTIONS:

MFD FOR:

The Wellness Center for Research

and Education, Inc.

1237 S. Victoria Ave. Suite 169

Oxnard, CA 93035

PACKAGE DISPLAY LABEL:

Formulated by DR. Theresa Dale

NDC#: 50181-0080-1

Serene 

Sleep

DR. DALE'S WELLNESS CENTER

Homeopathic

1 fluid oz. (30 ml)

INGREDIENTS AND APPEARANCE

SERENE SLEEP 
eschscholtzia californica, chamomilla, cina, coffea cruda, nux vomica, passiflora incarnata, pulsatilla (pratensis), ignatia amara, kali phosphoricum, rhus tox spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50181-0080
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ESCHSCHOLZIA CALIFORNICA WHOLE (UNII: 9315HN272X) (ESCHSCHOLZIA CALIFORNICA - UNII:9315HN272X)	ESCHSCHOLZIA CALIFORNICA WHOLE	3 [hp_C]  in 1 mL
MATRICARIA CHAMOMILLA WHOLE (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ)	MATRICARIA CHAMOMILLA WHOLE	3 [hp_C]  in 1 mL
ARTEMISIA CINA PRE-FLOWERING TOP (UNII: 28M1820ACT) (ARTEMISIA CINA FLOWER - UNII:28M1820ACT)	ARTEMISIA CINA PRE-FLOWERING TOP	6 [hp_C]  in 1 mL
ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72)	ARABICA COFFEE BEAN	6 [hp_C]  in 1 mL
STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919)	STRYCHNOS NUX-VOMICA SEED	6 [hp_C]  in 1 mL
PASSIFLORA INCARNATA FLOWERING TOP (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA FLOWERING TOP - UNII:CLF5YFS11O)	PASSIFLORA INCARNATA FLOWERING TOP	6 [hp_C]  in 1 mL
PULSATILLA PRATENSIS WHOLE (UNII: 8E272251DI) (PULSATILLA PRATENSIS WHOLE - UNII:8E272251DI)	PULSATILLA PRATENSIS WHOLE	6 [hp_C]  in 1 mL
STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (STRYCHNOS IGNATII SEED - UNII:1NM3M2487K)	STRYCHNOS IGNATII SEED	30 [hp_C]  in 1 mL
DIBASIC POTASSIUM PHOSPHATE (UNII: CI71S98N1Z) (PHOSPHATE ION - UNII:NK08V8K8HR)	DIBASIC POTASSIUM PHOSPHATE	30 [hp_C]  in 1 mL
TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A)	TOXICODENDRON PUBESCENS LEAF	30 [hp_C]  in 1 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50181-0080-1	30 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	02/14/2022	03/22/2027

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		02/14/2022	03/22/2027

Labeler - The Wellness Center for Research a (832363993)

Registrant - Apotheca Company (844330915)

Establishment
Name	Address	ID/FEI	Business Operations
Apotheca Company		844330915	manufacture(50181-0080) , api manufacture(50181-0080) , label(50181-0080) , pack(50181-0080)