Label: GOOD NIGHT SLEEP- aconitum nap,aesculus hipp, flos, avena, cocculus, coffea cruda, hyoscyamus, ignatia, passiflora, pulsatilla nutt, staphysag, 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 December 25, 2023

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  • HPUS Active Ingredients

    HPUS Active Ingredients: Equal volumes of each ingrediet in 10X, 30X, 1LM potencies. Aconitum nap, Aesculus hipp, flos, Avena, Cocculus, Coffea cruda, Hysocyamus, Ignatia, Passiflora, Pusatilla nutt, Staphysag, Valeriana.

  • Uses*

    Uses*: Temporarily relieves symptoms of occasional sleeplessness.

    *This statement has not been evaluated by the food and Drug Administration. This product is not inteded to diagnose, treat, cure or prevent any disease.

  • Warnings

    If symptoms persist or worsen, consult a healthcare professional. If pregnant or breastfeeding, ask a healthcare professional before use. Keep this and all medication out of reach of children.

  • Directions

    Initially, 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 saftey seal is intact.

  • Inactive Ingredients

    Inactive Ingredients: Purified water, carya ovata bark extract (hickory), citrust extract, Lonicera japonica (honeysuckle), polylysine (natural ferment), steviol glycosides (stevia).

  • Inactive Ingredients

    Inactive Ingredients: Purified water, carya ovata bark extract (hickory), citrust extract, Lonicera japonica (honeysuckle), polylysine (natural ferment), steviol glycosides (stevia).

  • 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 healthcare professional before use.

  • PURPOSE

    Temporarily relieves symptoms of occasional sleeplessness

  • PRINCIPAL DISPLAY PANEL

    Label image

  • INGREDIENTS AND APPEARANCE
    GOOD NIGHT SLEEP 
    aconitum nap,aesculus hipp, flos, avena, cocculus, coffea cruda, hyoscyamus, ignatia, passiflora, pulsatilla nutt, staphysag, valeriana spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68703-346
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    STRYCHNOS IGNATII WHOLE (UNII: 6YSJ329777) (STRYCHNOS IGNATII WHOLE - UNII:6YSJ329777) STRYCHNOS IGNATII WHOLE10 [hp_X]  in 59 mL
    COFFEA ARABICA FRUIT (UNII: HOX6BEK27Q) (COFFEA ARABICA FRUIT - UNII:HOX6BEK27Q) COFFEA ARABICA FRUIT10 [hp_X]  in 59 mL
    ANEMONE PATENS WHOLE (UNII: 4M1169RWJD) (ANEMONE PATENS WHOLE - UNII:4M1169RWJD) ANEMONE PATENS WHOLE10 [hp_X]  in 59 mL
    VALERIANA OFFICINALIS WHOLE (UNII: FP6O7F1X9R) (VALERIANA OFFICINALIS WHOLE - UNII:FP6O7F1X9R) VALERIANA OFFICINALIS WHOLE10 [hp_X]  in 59 mL
    AVENA SATIVA LEAF (UNII: 206PI19V7R) (AVENA SATIVA LEAF - UNII:206PI19V7R) AVENA SATIVA LEAF10 [hp_X]  in 59 mL
    PASSIFLORA INCARNATA FLOWER (UNII: K8F3G29S6Z) (PASSIFLORA INCARNATA FLOWER - UNII:K8F3G29S6Z) PASSIFLORA INCARNATA FLOWER10 [hp_X]  in 59 mL
    ANAMIRTA COCCULUS SEED (UNII: 810258W28U) (ANAMIRTA COCCULUS SEED - UNII:810258W28U) ANAMIRTA COCCULUS SEED10 [hp_X]  in 59 mL
    DELPHINIUM STAPHISAGRIA SEED (UNII: 00543AP1JV) (DELPHINIUM STAPHISAGRIA SEED - UNII:00543AP1JV) DELPHINIUM STAPHISAGRIA SEED10 [hp_X]  in 59 mL
    ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS10 [hp_X]  in 59 mL
    AESCULUS HIPPOCASTANUM FLOWER (UNII: KK0Z92II8M) (AESCULUS HIPPOCASTANUM FLOWER - UNII:KK0Z92II8M) AESCULUS HIPPOCASTANUM FLOWER10 [hp_X]  in 59 mL
    HYOSCYAMUS NIGER (UNII: 4WRK2153H3) (HYOSCYAMUS NIGER - UNII:4WRK2153H3) HYOSCYAMUS NIGER10 [hp_X]  in 59 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    LONICERA JAPONICA FLOWER (UNII: 4465L2WS4Y)  
    CARYA OVATA BARK (UNII: X765CF609L)  
    GLUCOSYL STEVIOL (UNII: TKD5UC898Q)  
    BENZYLPENICILLOYL POLYLYSINE (UNII: 76479814OY)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68703-346-0259 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product10/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic10/01/2019
    Labeler - Silver Star Brands (006070379)
    Registrant - Silver Star Brands (006070379)
    Establishment
    NameAddressID/FEIBusiness Operations
    King Bio617901350manufacture(68703-346)
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