Label: GOOD NIGHT SLEEP- aconitum nap, aesculus hipp, flos, avena, cocculus, coffea cruda, hyoscyamus, ignatia, passiflora, pulsatilla nutt, staphysagria, valeriana 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 January 25, 2022

If you are a consumer or patient please visit this version.

View All Sections
  • HPUS Active Ingredients

    HPUS Active Ingredients: Equal volumes of each ingredient in 10X, 15X, 30X potencies: Aconitum nap, Aesculus hipp, flos, Avena, Cocculus, coffea cruda, Hyoscyamus, Ignatia, Passiflora, Pulsatilla nutt, Staphysagrai, Valeriana.

  • Uses*:

    Uses*: Temporarily relieves symptoms of occasional sleeplessness.

    *Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

  • Warnings

    Warnings:

    If symptoms persist or worsen, consulta healthcare professional. if pregnant or breastfeeding, ask a health professional before use. keep this and all medication out of reach of children. in case of overdose, get medical help or contact a Poison Control Center right away.

  • Directions

    Directions: Intially, depress pump until primed. Hold close to mouth and spray directly into mouth. Adults and children 12+: 3 sprays, 3 times per day. Children 2-12: 2 sprays, 3 times per day. Use additionally as needed, up to 6 times per day.

  • OTHER SAFETY INFORMATION

    Contains no artificial flavors or colorants. No gluten added.

    Tamper resistant for your protection. use only if safety seal is intact.

  • Inactive Ingredients

    Inactive Ingredients: Ethyl alcohol, glycerin, purified water.

  • KEEP OUT OF REACH OF CHILDREN

    Keep this and all medication out of reach of children.

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breastfeeding, ask a health professional before use.

  • PURPOSE

    Temporarily relieves symptoms of occasional sleeplessness*

    *claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

  • PRINCIPAL DISPLAY PANEL

    Good Night Sleep

  • INGREDIENTS AND APPEARANCE
    GOOD NIGHT SLEEP 
    aconitum nap, aesculus hipp, flos, avena, cocculus, coffea cruda, hyoscyamus, ignatia, passiflora, pulsatilla nutt, staphysagria, valeriana spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68703-381
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ANEMONE NEMOROSA EXTRACT (UNII: 9IH59MK596) (ANEMONE NEMOROSA EXTRACT - UNII:9IH59MK596) ANEMONE NEMOROSA EXTRACT10 [hp_X]  in 59 mL
    DELPHINIUM STAPHISAGRIA SEED (UNII: 00543AP1JV) (DELPHINIUM STAPHISAGRIA SEED - UNII:00543AP1JV) DELPHINIUM STAPHISAGRIA SEED10 [hp_X]  in 59 mL
    STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (STRYCHNOS IGNATII SEED - UNII:1NM3M2487K) STRYCHNOS IGNATII SEED10 [hp_X]  in 59 mL
    ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS10 [hp_X]  in 59 mL
    COFFEA ARABICA FRUIT (UNII: HOX6BEK27Q) (COFFEA ARABICA FRUIT - UNII:HOX6BEK27Q) COFFEA ARABICA FRUIT10 [hp_X]  in 59 mL
    HYOSCYAMUS NIGER (UNII: 4WRK2153H3) (HYOSCYAMUS NIGER - UNII:4WRK2153H3) HYOSCYAMUS NIGER10 [hp_X]  in 59 mL
    AESCULUS HIPPOCASTANUM FLOWER (UNII: KK0Z92II8M) (AESCULUS HIPPOCASTANUM FLOWER - UNII:KK0Z92II8M) AESCULUS HIPPOCASTANUM FLOWER10 [hp_X]  in 59 mL
    PASSIFLORA INCARNATA FLOWER (UNII: K8F3G29S6Z) (PASSIFLORA INCARNATA FLOWER - UNII:K8F3G29S6Z) PASSIFLORA INCARNATA FLOWER10 [hp_X]  in 59 mL
    VALERIAN (UNII: JWF5YAW3QW) (VALERIAN - UNII:JWF5YAW3QW) VALERIAN10 [hp_X]  in 59 mL
    AVENA SATIVA LEAF (UNII: 206PI19V7R) (AVENA SATIVA LEAF - UNII:206PI19V7R) AVENA SATIVA LEAF10 [hp_X]  in 59 mL
    ANAMIRTA COCCULUS SEED (UNII: 810258W28U) (ANAMIRTA COCCULUS SEED - UNII:810258W28U) ANAMIRTA COCCULUS SEED10 [hp_X]  in 59 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68703-381-0259 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product03/15/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic03/15/2022
    Labeler - Silver Star Brands (006070379)
    Registrant - Silver Star Brands (006070379)
    Establishment
    NameAddressID/FEIBusiness Operations
    OHM Pharma, Inc.030572478manufacture(68703-381)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!