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

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

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.

Drug Label Information

Updated February 14, 2022

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  • 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

  • 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 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)
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