SERENE SLEEP- eschscholtzia californica, chamomilla, cina, coffea cruda, nux vomica, passiflora incarnata, pulsatilla (pratensis), ignatia amara, kali phosphoricum, rhus tox spray 
The Wellness Center for Research a

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:

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)

Serene Sleep

SERENE SLEEP 
eschscholtzia californica, chamomilla, cina, coffea cruda, nux vomica, passiflora incarnata, pulsatilla (pratensis), ignatia amara, kali phosphoricum, rhus tox spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50181-0080
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ESCHSCHOLZIA CALIFORNICA WHOLE (UNII: 9315HN272X) (ESCHSCHOLZIA CALIFORNICA - UNII:9315HN272X) ESCHSCHOLZIA CALIFORNICA WHOLE3 [hp_C]  in 1 mL
MATRICARIA CHAMOMILLA WHOLE (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ) MATRICARIA CHAMOMILLA WHOLE3 [hp_C]  in 1 mL
ARTEMISIA CINA PRE-FLOWERING TOP (UNII: 28M1820ACT) (ARTEMISIA CINA FLOWER - UNII:28M1820ACT) ARTEMISIA CINA PRE-FLOWERING TOP6 [hp_C]  in 1 mL
ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72) ARABICA COFFEE BEAN6 [hp_C]  in 1 mL
STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919) STRYCHNOS NUX-VOMICA SEED6 [hp_C]  in 1 mL
PASSIFLORA INCARNATA FLOWERING TOP (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA FLOWERING TOP - UNII:CLF5YFS11O) PASSIFLORA INCARNATA FLOWERING TOP6 [hp_C]  in 1 mL
PULSATILLA PRATENSIS WHOLE (UNII: 8E272251DI) (PULSATILLA PRATENSIS WHOLE - UNII:8E272251DI) PULSATILLA PRATENSIS WHOLE6 [hp_C]  in 1 mL
STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (STRYCHNOS IGNATII SEED - UNII:1NM3M2487K) STRYCHNOS IGNATII SEED30 [hp_C]  in 1 mL
DIBASIC POTASSIUM PHOSPHATE (UNII: CI71S98N1Z) (PHOSPHATE ION - UNII:NK08V8K8HR) DIBASIC POTASSIUM PHOSPHATE30 [hp_C]  in 1 mL
TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A) TOXICODENDRON PUBESCENS LEAF30 [hp_C]  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50181-0080-130 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product02/14/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic02/14/2022
Labeler - The Wellness Center for Research a (832363993)
Registrant - Apotheca Company (844330915)
Establishment
NameAddressID/FEIBusiness Operations
Apotheca Company844330915manufacture(50181-0080) , api manufacture(50181-0080) , label(50181-0080) , pack(50181-0080)

Revised: 2/2022
Document Id: 675393a5-8656-4e9d-a6f0-5c7b3186fb67
Set id: 2d5bbd0d-9b50-45ce-aa23-05bd05b54645
Version: 1
Effective Time: 20220214
 
The Wellness Center for Research a