Allergies™ Great Lakes U.S.

ALLERGIES GREAT LAKES U.S.- adenosinum cyclophosphoricum, adrenalinum, adrenocorticotrophin, allium cepa, ambrosia artemisiaefolia, chelidonium majus, chenopodium vulvaria, cichorium intybus, cortisone aceticum, euphrasia officinalis, galphimia glauca, hedera helix, histaminum hydrochloricum, juglans cinerea, kali muriaticum, mucosa nasalis suis, natrum muriaticum, pulsatilla nuttalliana, rna, sabadilla, teucrium scorodonia liquid
King Bio Inc.

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

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Drug Facts__________________________________________________________________________________________________________

HPUS active ingredients: Adenosinum cyclophosphoricum, Adrenalinum, Adrenocorticotrophin, Allium cepa, Ambrosia artemisiaefolia, Chelidonium majus, Chenopodium vulvaria, Cichorium intybus, Cortisone aceticum, Euphrasia officinalis, Galphimia glauca, Hedera helix, Histaminum hydrochloricum, Juglans cinerea, Kali muriaticum, Mucosa nasalis suis, Natrum muriaticum, Pulsatilla nuttalliana, RNA, Sabadilla, Teucrium scorodonia. Equal volumes of each ingredient in 12X, 24X, 30X, LM1, LM2, LM3, LM5 potencies.

Uses for temporary relief of symptoms: red, itchy, watery eyes, sore throat, cough, hoarseness, fatigue, runny nose, sneezing, congestion, and headache.

Inactive Ingredients:

Bio-Energetically Enhanced™ pure water, citric acid and potassium sorbate.

Warnings

Stop use and ask your doctor if symptoms persist or worsen.
If pregnant or breast-feeding, take only on advice of a healthcare professional.

Keep out of reach of children.

Directions

Initially, depress pump until primed.
Spray one dose directly into mouth.
Adults 12 and up: 3 sprays 3 times per day.
Children 2-12: 2 sprays 3 times per day.
Children 2 mo-2 yr: 1 spray 3 times per day.

Tamper resistant for your protection. Use only if seal is intact. This product has not been independently tested.

Uses for temporary relief of symptoms:

red, itchy, watery eyes
sore throat
cough
hoarseness
fatigue
runny nose
sneezing
congestion
headache

image description

ALLERGIES GREAT LAKES U.S.
adenosinum cyclophosphoricum, adrenalinum, adrenocorticotrophin, allium cepa, ambrosia artemisiaefolia, chelidonium majus, chenopodium vulvaria, cichorium intybus, cortisone aceticum, euphrasia officinalis, galphimia glauca, hedera helix, histaminum hydrochloricum, juglans cinerea, kali muriaticum, mucosa nasalis suis, natrum muriaticum, pulsatilla nuttalliana, rna, sabadilla, teucrium scorodonia liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:57955-2708
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ADENOSINE CYCLIC PHOSPHATE (UNII: E0399OZS9N) (ADENOSINE CYCLIC 3',5'-PHOSPHATE - UNII:E0399OZS9N)	ADENOSINE CYCLIC PHOSPHATE	12 [hp_X] in 59 mL
EPINEPHRINE (UNII: YKH834O4BH) (EPINEPHRINE - UNII:YKH834O4BH)	EPINEPHRINE	12 [hp_X] in 59 mL
CORTICOTROPIN (UNII: K0U68Q2TXA) (CORTICOTROPIN - UNII:K0U68Q2TXA)	CORTICOTROPIN	12 [hp_X] in 59 mL
ONION (UNII: 492225Q21H) (ONION - UNII:492225Q21H)	ONION	12 [hp_X] in 59 mL
AMBROSIA ARTEMISIIFOLIA (UNII: 9W34L2CQ9A) (AMBROSIA ARTEMISIIFOLIA - UNII:9W34L2CQ9A)	AMBROSIA ARTEMISIIFOLIA	12 [hp_X] in 59 mL
CHELIDONIUM MAJUS (UNII: 7E889U5RNN) (CHELIDONIUM MAJUS - UNII:7E889U5RNN)	CHELIDONIUM MAJUS	12 [hp_X] in 59 mL
CHENOPODIUM VULVARIA (UNII: 0VSD1H8IW4) (CHENOPODIUM VULVARIA - UNII:0VSD1H8IW4)	CHENOPODIUM VULVARIA	12 [hp_X] in 59 mL
CHICORY ROOT (UNII: 090CTY533N) (CHICORY ROOT - UNII:090CTY533N)	CHICORY ROOT	12 [hp_X] in 59 mL
CORTISONE ACETATE (UNII: 883WKN7W8X) (CORTISONE - UNII:V27W9254FZ)	CORTISONE ACETATE	12 [hp_X] in 59 mL
EUPHRASIA STRICTA (UNII: C9642I91WL) (EUPHRASIA STRICTA - UNII:C9642I91WL)	EUPHRASIA STRICTA	12 [hp_X] in 59 mL
GALPHIMIA GLAUCA FLOWERING TOP (UNII: 93PH5Q8M7E) (GALPHIMIA GLAUCA FLOWERING TOP - UNII:93PH5Q8M7E)	GALPHIMIA GLAUCA FLOWERING TOP	12 [hp_X] in 59 mL
HEDERA HELIX FLOWERING TWIG (UNII: 3D10KUA6BM) (HEDERA HELIX FLOWERING TWIG - UNII:3D10KUA6BM)	HEDERA HELIX FLOWERING TWIG	12 [hp_X] in 59 mL
HISTAMINE DIHYDROCHLORIDE (UNII: 3POA0Q644U) (HISTAMINE - UNII:820484N8I3)	HISTAMINE DIHYDROCHLORIDE	12 [hp_X] in 59 mL
JUGLANS CINEREA BRANCH BARK/ROOT BARK (UNII: 48FZ1BHO18) (JUGLANS CINEREA BRANCH BARK/ROOT BARK - UNII:48FZ1BHO18)	JUGLANS CINEREA BRANCH BARK/ROOT BARK	12 [hp_X] in 59 mL
POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152)	POTASSIUM CATION	12 [hp_X] in 59 mL
SUS SCROFA NASAL MUCOSA (UNII: ID3Z1X61WY) (SUS SCROFA NASAL MUCOSA - UNII:ID3Z1X61WY)	SUS SCROFA NASAL MUCOSA	12 [hp_X] in 59 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698)	SODIUM CHLORIDE	12 [hp_X] in 59 mL
ANEMONE PATENS (UNII: 4M1169RWJD) (ANEMONE PATENS - UNII:4M1169RWJD)	ANEMONE PATENS	12 [hp_X] in 59 mL
SACCHAROMYCES CEREVISIAE RNA (UNII: J17GBZ5VGX) (SACCHAROMYCES CEREVISIAE RNA - UNII:J17GBZ5VGX)	SACCHAROMYCES CEREVISIAE RNA	12 [hp_X] in 59 mL
SCHOENOCAULON OFFICINALE SEED (UNII: 6NAF1689IO) (SCHOENOCAULON OFFICINALE SEED - UNII:6NAF1689IO)	SCHOENOCAULON OFFICINALE SEED	12 [hp_X] in 59 mL
TEUCRIUM SCORODONIA FLOWERING TOP (UNII: LOK3I16O7G) (TEUCRIUM SCORODONIA FLOWERING TOP - UNII:LOK3I16O7G)	TEUCRIUM SCORODONIA FLOWERING TOP	12 [hp_X] in 59 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:57955-2708-2	59 mL in 1 BOTTLE, SPRAY

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		06/20/2014

Labeler - King Bio Inc. (617901350)

Registrant - King Bio Inc. (617901350)

Name	Address	ID/FEI	Business Operations
Establishment
King Bio Inc.		617901350	manufacture(57955-2708)