Label: REGIONAL ALLERGIES SOUTHWESTERN U.S.- adenosinum cyclophosphoricum, adrenalinum, adrenocorticotrophin, allium cepa, asarum canadense, cortisone aceticum, eupatorium aromaticum, euphrasia officinalis, fraxinus americana, galphimia glauca, helianthus annuus, histaminum hydrochloricum, juniperus virginiana, kali muriaticum, mucosa nasalis suis, natrum muriaticum, plantago major, rna, rumex crispus, sabadilla, senecio jacobaea liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 57955-0761-2 - Packager: King Bio Inc.
- Category: HUMAN OTC DRUG LABEL
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.
Drug Label Information
Updated July 9, 2020
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
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ACTIVE INGREDIENT
Drug Facts__________________________________________________________________________________________________________
HPUS active ingredients: Adenosinum cyclophosphoricum, Adrenalinum, Adrenocorticotrophin (30X), Allium cepa, Asarum canadense, Cortisone aceticum, Eupatorium aromaticum, Euphrasia officinalis, Fraxinus americana, Galphimia glauca, Helianthus annuus, Histaminum hydrochloricum, Juniperus virginiana, Kali muriaticum, Mucosa nasalis suis, Natrum muriaticum, Plantago major, RNA, Rumex crispus, Sabadilla, Senecio jacobaea. Equal volumes of each ingredient in 12X, 30X, and 1LM potencies.
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INDICATIONS & USAGE
Uses for temporary relief of allergy symptoms commonly
experienced in OK, TX: █ itchy, watery eyes █ runny nose
█ sneezing █ sore throat █ sinus congestion █ cough █ stuffy
nose █ fatigue █ itchy, irritated skin █ hoarseness █ headache.
† as per various homeopathic materia medicas. Claims based
on traditional homeopathic practice, not accepted medical
evidence. These uses have not been evaluated by the FDA,
and product has not been clinically tested.. - WARNINGS
- DOSAGE & ADMINISTRATION
- STORAGE AND HANDLING
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INACTIVE INGREDIENT
Inactive Ingredients:
Bio-Energetically Enhanced™ pure
water, citrus extract* (ascorbic
acid, citric acid, citrus aurantium
amara fruit extract, citrus
aurantium sinensis peel extract,
citrus reticulata fruit extract,
demineralized water, glycerin,
lactic acid), Honeysuckle (Lonicera
japonica), polylysine, Shagbark
Hickory (Carya ovata) Bark
Extract, steviol (Steviol
glycosides). -
PURPOSE
Drug Facts
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HPUS active ingredients Purpose
Equal volumes of each HPUS** ingredient in 12X, 30X, and 1LM
potencies unless otherwise noted.
Adenosinum cyclophosphoricum..............headache, runny nose
Adrenalinum ............ hay fever, stuffed sinuses, lung congestion
Adrenocorticotrophin (30X) ............................congestion, cough
Allium cepa........................hay fever, sinus headache, sneezing
Asarum canadense .......................head congestion, runny nose
Cortisone aceticum.............................allergic reaction, irritability
Eupatorium aromaticum ........................ headache, restlessness
Euphrasia officinalis..................itchy skin around eyes and nose
Fraxinus americana............................. nervousness, hot flushes
Galphimia glauca.................................... puffy eyelids, hay fever
Helianthus annuus..................mucous cough, hoarse, dry throat
Histaminum hydrochloricum...................coughing, itching throat
Juniperus virginiana .............................................. eye twitching
Kali muriaticum......................................hoarseness, stuffy nose
Mucosa nasalis suis ..............sinus headache, nasal congestion
Natrum muriaticum...................................watery eyes, sneezing
Plantago major..............................eye, ear and face tenderness
RNA..................................................................allergic reactions
Rumex crispus..................... throat with much mucus, dry cough
Sabadilla.................................sore throat, runny nose, sneezing
Senecio jacobaea......................fatigue, headaches, foggy mind
**“HPUS” indicates the active ingredients are in the official
Homeopathic Pharmacopeia of the United States. - QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
REGIONAL ALLERGIES SOUTHWESTERN U.S.
adenosinum cyclophosphoricum, adrenalinum, adrenocorticotrophin, allium cepa, asarum canadense, cortisone aceticum, eupatorium aromaticum, euphrasia officinalis, fraxinus americana, galphimia glauca, helianthus annuus, histaminum hydrochloricum, juniperus virginiana, kali muriaticum, mucosa nasalis suis, natrum muriaticum, plantago major, rna, rumex crispus, sabadilla, senecio jacobaea liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:57955-0761 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ADENOSINE CYCLIC PHOSPHATE (UNII: E0399OZS9N) (ADENOSINE CYCLIC 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 30 [hp_X] in 59 mL ONION (UNII: 492225Q21H) (ONION - UNII:492225Q21H) ONION 12 [hp_X] in 59 mL ASARUM CANADENSE ROOT (UNII: E2O4O7TQYK) (ASARUM CANADENSE ROOT - UNII:E2O4O7TQYK) ASARUM CANADENSE ROOT 12 [hp_X] in 59 mL CORTISONE ACETATE (UNII: 883WKN7W8X) (CORTISONE - UNII:V27W9254FZ) CORTISONE ACETATE 12 [hp_X] in 59 mL AGERATINA AROMATICA ROOT (UNII: P363RWH4NW) (AGERATINA AROMATICA ROOT - UNII:P363RWH4NW) AGERATINA AROMATICA ROOT 12 [hp_X] in 59 mL EUPHRASIA STRICTA (UNII: C9642I91WL) (EUPHRASIA STRICTA - UNII:C9642I91WL) EUPHRASIA STRICTA 12 [hp_X] in 59 mL FRAXINUS AMERICANA BARK (UNII: 0B24UR1O1S) (FRAXINUS AMERICANA BARK - UNII:0B24UR1O1S) FRAXINUS AMERICANA BARK 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 HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP) (HELIANTHUS ANNUUS FLOWERING TOP - UNII:BKJ0J3D1BP) HELIANTHUS ANNUUS FLOWERING TOP 12 [hp_X] in 59 mL HISTAMINE DIHYDROCHLORIDE (UNII: 3POA0Q644U) (HISTAMINE - UNII:820484N8I3) HISTAMINE DIHYDROCHLORIDE 12 [hp_X] in 59 mL JUNIPERUS VIRGINIANA TWIG (UNII: 532BCG080L) (JUNIPERUS VIRGINIANA TWIG - UNII:532BCG080L) JUNIPERUS VIRGINIANA TWIG 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 PLANTAGO MAJOR (UNII: W2469WNO6U) (PLANTAGO MAJOR - UNII:W2469WNO6U) PLANTAGO MAJOR 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 RUMEX CRISPUS ROOT (UNII: 9N1RM2S62C) (RUMEX CRISPUS ROOT - UNII:9N1RM2S62C) RUMEX CRISPUS ROOT 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 JACOBAEA VULGARIS (UNII: 31M57289I3) (JACOBAEA VULGARIS - UNII:31M57289I3) JACOBAEA VULGARIS 12 [hp_X] in 59 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CARYA OVATA BARK (UNII: X765CF609L) CITRUS BIOFLAVONOIDS (UNII: BD70459I50) LONICERA JAPONICA FLOWER (UNII: 4465L2WS4Y) POLYEPSILON-LYSINE (4000 MW) (UNII: WB0M8X4TWR) REBAUDIOSIDE A (UNII: B3FUD0528F) Product Characteristics Color Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:57955-0761-2 1 in 1 CARTON 04/10/2018 1 59 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 04/10/2018 Labeler - King Bio Inc. (617901350) Registrant - King Bio Inc. (617901350) Establishment Name Address ID/FEI Business Operations King Bio Inc. 617901350 manufacture(57955-0761) , api manufacture(57955-0761)