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

  • 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 September 18, 2023

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  • 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

  • INGREDIENTS AND APPEARANCE
    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)
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