Good Night Sleep
Good Night Sleep is an FDA drug label for the active ingredient ACONITUM NAP, AESCULUS HIPP, FLOS, AVENA, COCCULUS, COFFEA CRUDA, HYOSCYAMUS, IGNATIA, PASSIFLORA, PULSATILLA NUTT, STAPHYSAGRIA, VALERIANA manufactured by Silver Star Brands administered by ORAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20220125.
- Generic name
- ACONITUM NAP, AESCULUS HIPP, FLOS, AVENA, COCCULUS, COFFEA CRUDA, HYOSCYAMUS, IGNATIA, PASSIFLORA, PULSATILLA NUTT, STAPHYSAGRIA, VALERIANA
- Manufacturer
- Silver Star Brands
- Product type
- HUMAN OTC DRUG
- Route
- ORAL
- Dosage form
- N/A
- NDC
- 68703-381
- Application
- N/A
- Label effective
- 20220125
About this product
Good Night Sleep is an FDA-registered drug product whose active ingredient is ACONITUM NAP, AESCULUS HIPP, FLOS, AVENA, COCCULUS, COFFEA CRUDA, HYOSCYAMUS, IGNATIA, PASSIFLORA, PULSATILLA NUTT, STAPHYSAGRIA, VALERIANA. It is labelled by Silver Star Brands taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 68703-381, label effective 20220125. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.
What it is used for
Across FDA labelling, products containing ACONITUM NAP, AESCULUS HIPP, FLOS, AVENA, COCCULUS, COFFEA CRUDA, HYOSCYAMUS, IGNATIA, PASSIFLORA, PULSATILLA NUTT, STAPHYSAGRIA, VALERIANA are most often described in connection with: temporarily relieves, symptoms occasional, sleeplessness claims, based traditional, homeopathic practice, accepted medical, fda evaluated. Wording differs between labels, and the full indications section on this page takes precedence when it is present.
Active ingredients
Indications & Usage
Uses*: Uses*: Temporarily relieves symptoms of occasional sleeplessness. *Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.
Dosage & Administration
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.
Warnings
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.
Recall and safety notices
5 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.
| Recall | Product | Firm | Class | Status | Reported |
|---|---|---|---|---|---|
| D-0256-2019 | Healthful Naturals Leg Cramp Support Oral Spray, 2 fl oz (59 mL) per bottle, Distributed by: Silver Star Brands, Oshkosh, WI 54906 NDC 68703-206-02 | Silver Star Brands | Class II | Terminated | 20181114 |
| D-0251-2019 | Native Remedies VertiFree Oral Spray, 2 fl oz (59 mL) per bottle, Distributed by: Silver Star Brands, Oshkosh, WI 54906. NDC 68703-253-02 | Silver Star Brands | Class I | Terminated | 20181114 |
| D-0253-2019 | Native Remedies VaricoGo Oral Spray, 2 fl oz (59 mL) per bottle, Distributed by: Silver Star Brands, Oshkosh, WI 54906. NDC 68703-105-59 | Silver Star Brands | Class I | Terminated | 20181114 |
| D-0252-2019 | Native Remedies HypoSlim Oral Spray, 2 fl oz (59 mL) per bottle, Distributed by: Silver Star Brands, Oshkosh, WI 54906. NDC 68703-275-02 | Silver Star Brands | Class I | Terminated | 20181114 |
| D-0254-2019 | Native Remedies EyeClear Pro Oral Spray, 2 fl oz (59 mL) per bottle, Distributed by: Silver Star Brands, Oshkosh, WI 54906. NDC 68703-151-59 | Silver Star Brands | Class I | Terminated | 20181114 |
Frequently asked questions
What is Good Night Sleep used for?
Uses*: Uses*: Temporarily relieves symptoms of occasional sleeplessness. *Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.
Who makes Good Night Sleep?
Silver Star Brands is the labeler of record for Good Night Sleep.
What form does Good Night Sleep come in?
administered by oral. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.
Is Good Night Sleep prescription or over-the-counter?
The FDA label for this product is recorded as human otc drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.
Has Good Night Sleep been recalled?
5 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.
Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.
This page reproduces FDA Structured Product Labelling data for identification and reference. It is not medical advice, does not diagnose or treat any condition, and does not sell or price any medicine.