SPRAYOLOGY STRESS RELIEF- agnus castus, avena sativa, cinchona officinalis, humulus lupulus, hyoscyamus niger, ignatia amara, passiflora incarnata, valeriana officinalis 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. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients: Agnus castus 6X, Avena sativa 1X, Cinchona officinalis 6X, Humulus lupulus 2X, Hyoscyamus niger 200C, Ignatia amara 200C, Passiflora incarnata 3X, Valeriana officinalis 3X

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.
• Ages 2 to 12: 1 spray into the mouth each 60 minutes as needed for symptom relief the first day, 1 spray 3 times a day thereafter.
• Under age 2: 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: Glycerin 10% v/v, non-GMO organic alcohol 9% v/v and purified water.

INDICATIONS & USAGE

Temporarily relieves feelings of stress, including:

° anxiety

° nervousness

° mood swings

° irritability

° natural

° gluten 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 castus, avena sativa, cinchona officinalis, humulus lupulus, hyoscyamus niger, ignatia amara, passiflora incarnata, valeriana officinalis liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61096-0006
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	1 [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	2 [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	3 [hp_X]  in 41 mL
VALERIAN (UNII: JWF5YAW3QW) (VALERIAN - UNII:JWF5YAW3QW)	VALERIAN	3 [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: 61096-0006-1	1 in 1 CARTON
1		41 mL in 1 BOTTLE, SPRAY

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		02/26/2014

Labeler - Eight and Company (927364120)

Registrant - Eight and Company (927364120)