SPRAYOLOGY STRESS RELIEF- agnus, avena, cinchona, humulus, hyoscyamus, ignatia, passiflora, valeriana liquid

Sprayology Stress Relief by

Drug Labeling and Warnings

Sprayology Stress Relief by is a Homeopathic medication manufactured, distributed, or labeled by Eight and Company L.L.C, Apotheca Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients: Agnus 6X, Avena 4X, Cinchona 6X, Humulus 4X, Hyoscyamus 200C, Ignatia 200C, Passiflora 4X, Valeriana 4X

WARNINGS

Warnings: If symptoms persist or worsen, stop use and seek advice of physician. If pregnant or breast-feeding, ask a health care professional before use. Keep out of reach of children. Contains alcohol, in case of overdose, get medical help or contact a Poison Control Center right away.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

DOSAGE & ADMINISTRATION

Directions:

• Adults and children over 12: 2 sprays into the mouth each 60 minutes as needed for symptom relief the first day, 2 sprays 3 times a day thereafter.
• Under age 12: consult a health care professional.

PURPOSE

Temporarily relieves feelings of stress, including:

• anxiety
• nervousness
• mood swings
• irritability

OTHER SAFETY INFORMATION

Other Information: Do not use if the transparent seal around spray bottle is broken or missing.

INACTIVE INGREDIENT

Inactive Ingredients: Non-GMO glycerin, organic alcohol 20% v/v and purified water.

INDICATIONS & USAGE

Temporarily relieves feelings of stress, including:

° anxiety

° nervousness

° mood swings

° irritability

° natural

° gluten & lactose free

° no artificial flavors or colors

° no known negative side effects

° no known negative drug interactions

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SPRAYOLOGY STRESS RELIEF 
agnus, avena, cinchona, humulus, hyoscyamus, ignatia, passiflora, valeriana liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61096-2006
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHASTE TREE (UNII: 433OSF3U8A) (CHASTE TREE - UNII:433OSF3U8A)	CHASTE TREE	6 [hp_X]  in 41 mL
AVENA SATIVA FLOWERING TOP (UNII: MA9CQJ3F7F) (AVENA SATIVA FLOWERING TOP - UNII:MA9CQJ3F7F)	AVENA SATIVA FLOWERING TOP	4 [hp_X]  in 41 mL
CINCHONA OFFICINALIS BARK (UNII: S003A158SB) (CINCHONA OFFICINALIS BARK - UNII:S003A158SB)	CINCHONA OFFICINALIS BARK	6 [hp_X]  in 41 mL
HOPS (UNII: 01G73H6H83) (HOPS - UNII:01G73H6H83)	HOPS	4 [hp_X]  in 41 mL
HYOSCYAMUS NIGER (UNII: 4WRK2153H3) (HYOSCYAMUS NIGER - UNII:4WRK2153H3)	HYOSCYAMUS NIGER	200 [hp_C]  in 41 mL
STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (STRYCHNOS IGNATII SEED - UNII:1NM3M2487K)	STRYCHNOS IGNATII SEED	200 [hp_C]  in 41 mL
PASSIFLORA INCARNATA FLOWERING TOP (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA FLOWERING TOP - UNII:CLF5YFS11O)	PASSIFLORA INCARNATA FLOWERING TOP	4 [hp_X]  in 41 mL
VALERIAN (UNII: JWF5YAW3QW) (VALERIAN - UNII:JWF5YAW3QW)	VALERIAN	4 [hp_X]  in 41 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61096-2006-1	1 in 1 CARTON	03/25/2019
1		41 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		03/25/2019

Labeler - Eight and Company L.L.C (927364120)

Registrant - Eight and Company L.L.C (927364120)