NativeRemedies® Good Night Sleep Oral Spray

Manufacturer
Silver Star Brands | OHM Pharma, Inc.
Effective date
2022-01-25
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:17:09

Label at a glance#

ProductGood Night Sleep
Active ingredientANEMONE NEMOROSA EXTRACT, DELPHINIUM STAPHISAGRIA SEED, STRYCHNOS IGNATII SEED, ACONITUM NAPELLUS, COFFEA ARABICA FRUIT, HYOSCYAMUS NIGER, AESCULUS HIPPOCASTANUM FLOWER, PASSIFLORA INCARNATA FLOWER, VALERIAN, AVENA SATIVA LEAF, ANAMIRTA COCCULUS SEED
Label structure10 sections

Indications and uses

Uses*: Temporarily relieves symptoms of occasional sleeplessness. *Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Dosage and administration

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.

Label contents#

Full prescribing information#

HPUS Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

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*:

INDICATIONS & USAGE SECTION

Uses*: Temporarily relieves symptoms of occasional sleeplessness.

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

Warnings

WARNINGS SECTION

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

DOSAGE & ADMINISTRATION SECTION

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 INGREDIENT SECTION

Inactive Ingredients: Ethyl alcohol, glycerin, purified water.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep this and all medication out of reach of children.

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - PURPOSE SECTION

Temporarily relieves symptoms of occasional sleeplessness*

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Good Night SleepGood Night Sleep

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68703-381-02Good Night Sleep59 mL in 1 BOTTLE, SPRAYSPRAY591

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68703-381GOOD NIGHT SLEEP (ACONITUM NAP, AESCULUS HIPP, FLOS, AVENA, COCCULUS, COFFEA CRUDA, HYOSCYAMUS, IGNATIA, PASSIFLORA, PULSATILLA NUTT, STAPHYSAGRIA, VALERIANA) SPRAY [SILVER STAR BRANDS]1Current NDC, Legacy NDC, 1 package rows20220315_d66d4ba2-8917-ae07-e053-2995a90abbd0.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68703-38168703-381-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Good Night SleepACONITUM NAP, AESCULUS HIPP, FLOS, AVENA, COCCULUS, COFFEA CRUDA, HYOSCYAMUS, IGNATIA, PASSIFLORA, PULSATILLA NUTT, STAPHYSAGRIA, VALERIANASilver Star Brandsd66d4ba2-8917-ae07-e053-2995a90abbd02022-01-25WarningsExact identifier
ndc (package): 68703-381-02
ndc (product): 68703-381
ndc11 (package): 68703038102
spl id: d66d4ba2-8918-ae07-e053-2995a90abbd0
spl set id: d66d4ba2-8917-ae07-e053-2995a90abbd0

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.