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.

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 this and all medication out of reach of children.

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

Temporarily relieves symptoms of occasional sleeplessness*

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

Good Night Sleep

GOOD NIGHT SLEEP
aconitum nap, aesculus hipp, flos, avena, cocculus, coffea cruda, hyoscyamus, ignatia, passiflora, pulsatilla nutt, staphysagria, valeriana spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:68703-381
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ANEMONE NEMOROSA EXTRACT (UNII: 9IH59MK596) (ANEMONE NEMOROSA EXTRACT - UNII:9IH59MK596)	ANEMONE NEMOROSA EXTRACT	10 [hp_X] in 59 mL
DELPHINIUM STAPHISAGRIA SEED (UNII: 00543AP1JV) (DELPHINIUM STAPHISAGRIA SEED - UNII:00543AP1JV)	DELPHINIUM STAPHISAGRIA SEED	10 [hp_X] in 59 mL
STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (STRYCHNOS IGNATII SEED - UNII:1NM3M2487K)	STRYCHNOS IGNATII SEED	10 [hp_X] in 59 mL
ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD)	ACONITUM NAPELLUS	10 [hp_X] in 59 mL
COFFEA ARABICA FRUIT (UNII: HOX6BEK27Q) (COFFEA ARABICA FRUIT - UNII:HOX6BEK27Q)	COFFEA ARABICA FRUIT	10 [hp_X] in 59 mL
HYOSCYAMUS NIGER (UNII: 4WRK2153H3) (HYOSCYAMUS NIGER - UNII:4WRK2153H3)	HYOSCYAMUS NIGER	10 [hp_X] in 59 mL
AESCULUS HIPPOCASTANUM FLOWER (UNII: KK0Z92II8M) (AESCULUS HIPPOCASTANUM FLOWER - UNII:KK0Z92II8M)	AESCULUS HIPPOCASTANUM FLOWER	10 [hp_X] in 59 mL
PASSIFLORA INCARNATA FLOWER (UNII: K8F3G29S6Z) (PASSIFLORA INCARNATA FLOWER - UNII:K8F3G29S6Z)	PASSIFLORA INCARNATA FLOWER	10 [hp_X] in 59 mL
VALERIAN (UNII: JWF5YAW3QW) (VALERIAN - UNII:JWF5YAW3QW)	VALERIAN	10 [hp_X] in 59 mL
AVENA SATIVA LEAF (UNII: 206PI19V7R) (AVENA SATIVA LEAF - UNII:206PI19V7R)	AVENA SATIVA LEAF	10 [hp_X] in 59 mL
ANAMIRTA COCCULUS SEED (UNII: 810258W28U) (ANAMIRTA COCCULUS SEED - UNII:810258W28U)	ANAMIRTA COCCULUS SEED	10 [hp_X] in 59 mL

Ingredient Name	Strength
Inactive Ingredients
ALCOHOL (UNII: 3K9958V90M)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:68703-381-02	59 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	03/15/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		03/15/2022

Labeler - Silver Star Brands (006070379)

Registrant - Silver Star Brands (006070379)

Name	Address	ID/FEI	Business Operations
Establishment
OHM Pharma, Inc.		030572478	manufacture(68703-381)

NativeRemedies® Good Night Sleep Oral Spray

HPUS Active Ingredients

Uses*:

Warnings

Directions

Inactive Ingredients