ALLERGEASE- allium cepa, apis mellifica, aralia rac, arundo, baptisia, echinacea, euphrasia, gelsemium, histaminum, lycopodium, rhus tox, sabadilla, sanguinaria, urtica ur. liquid

AllergEase by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients: Allium cepa 6X, Apis mel 4X, Aralia rac 6X, Arundo 30C, Baptisia 4X, Echinacea 4X, Euphrasia 6X, Gelsemium 200C, Histaminum hydrochloricum 12X, Lycopodium 6X, Rhus tox 200C, Sabadilla 6X, Sanguinaria 200C, Urtica ur 4X, 200C.

WARNINGS

Warnings: If symptoms persist or worsen, 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 30 minutes as needed for symptom relief the first day. 2 sprays 3 times a day thereafter.
• Children under 12 consult a health care professional.

PURPOSE

Temporarily relieves the symptoms of allergies and hay fever, including:

• runny nose
• itchy eyes
• rash
• headache and sneezing

OTHER SAFETY INFORMATION

Other Information:

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

INACTIVE INGREDIENT

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

INDICATIONS & USAGE

Temporarily relieves the symptoms of allergies and hay fever, including:

• runny nose
• itchy eyes
• rash
• headache and sneezing

-natural

-gluten & lcactose free

-no artifical flavors or colors

-no known negative side effects

-no known negative drug interactions

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ALLERGEASE 
allium cepa, apis mellifica, aralia rac, arundo, baptisia, echinacea, euphrasia, gelsemium, histaminum, lycopodium, rhus tox, sabadilla, sanguinaria, urtica ur. liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61096-1003
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ONION (UNII: 492225Q21H) (ONION - UNII:492225Q21H)	ONION	6 [hp_X]  in 41 mL
APIS MELLIFERA (UNII: 7S82P3R43Z) (APIS MELLIFERA - UNII:7S82P3R43Z)	APIS MELLIFERA	4 [hp_X]  in 41 mL
ARALIA RACEMOSA ROOT (UNII: T90W4582DU) (ARALIA RACEMOSA ROOT - UNII:T90W4582DU)	ARALIA RACEMOSA ROOT	6 [hp_X]  in 41 mL
ARUNDO PLINIANA ROOT (UNII: ZXE7LB03WC) (ARUNDO PLINIANA ROOT - UNII:ZXE7LB03WC)	ARUNDO PLINIANA ROOT	30 [hp_C]  in 41 mL
BAPTISIA TINCTORIA ROOT (UNII: 5EF0HWI5WU) (BAPTISIA TINCTORIA ROOT - UNII:5EF0HWI5WU)	BAPTISIA TINCTORIA ROOT	4 [hp_X]  in 41 mL
ECHINACEA, UNSPECIFIED (UNII: 4N9P6CC1DX) (ECHINACEA, UNSPECIFIED - UNII:4N9P6CC1DX)	ECHINACEA, UNSPECIFIED	4 [hp_X]  in 41 mL
EUPHRASIA STRICTA (UNII: C9642I91WL) (EUPHRASIA STRICTA - UNII:C9642I91WL)	EUPHRASIA STRICTA	6 [hp_X]  in 41 mL
GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q)	GELSEMIUM SEMPERVIRENS ROOT	200 [hp_C]  in 41 mL
HISTAMINE DIHYDROCHLORIDE (UNII: 3POA0Q644U) (HISTAMINE - UNII:820484N8I3)	HISTAMINE DIHYDROCHLORIDE	12 [hp_X]  in 41 mL
LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479)	LYCOPODIUM CLAVATUM SPORE	6 [hp_X]  in 41 mL
TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A)	TOXICODENDRON PUBESCENS LEAF	200 [hp_C]  in 41 mL
SCHOENOCAULON OFFICINALE SEED (UNII: 6NAF1689IO) (SCHOENOCAULON OFFICINALE SEED - UNII:6NAF1689IO)	SCHOENOCAULON OFFICINALE SEED	6 [hp_X]  in 41 mL
SANGUINARIA CANADENSIS ROOT (UNII: N9288CD508) (SANGUINARIA CANADENSIS ROOT - UNII:N9288CD508)	SANGUINARIA CANADENSIS ROOT	200 [hp_C]  in 41 mL
URTICA URENS (UNII: IHN2NQ5OF9) (URTICA URENS - UNII:IHN2NQ5OF9)	URTICA URENS	200 [hp_C]  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: 61096-1003-1	1 in 1 CARTON	02/26/2019
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		02/26/2019

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

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