Regional Allergies Great Lakes U.s.

Regional Allergies Great Lakes U.s.
SPL v4
SPL
SPL Set ID 4c64dfca-1e43-4486-9f63-6c0f1cccb12a
Route
ORAL
Published
Effective Date 2020-06-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Adenosine Cyclic Phosphate (12 [hp_X]) Epinephrine (30 [hp_X]) Corticotropin Onion Ambrosia Artemisiifolia Chelidonium Majus Chenopodium Vulvaria Chicory Root Cortisone Euphrasia Stricta Galphimia Glauca Flowering Top Hedera Helix Flowering Twig Histamine Juglans Cinerea Branch Bark/root Bark Potassium Cation Sus Scrofa Nasal Mucosa Chloride Ion Pulsatilla Patens Whole Saccharomyces Cerevisiae Rna Schoenocaulon Officinale Seed Teucrium Scorodonia Flowering Top
Inactive Ingredients
Water Carya Ovata Bark Citrus Bioflavonoids Lonicera Japonica Flower Polyepsilon-lysine (4000 Mw) Rebaudioside A

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2018-04-11

Description

Drug Facts ​__________________________________________________________________________________________________________ HPUS active ingredients: ​Adenosinum cyclophosphoricum, Adrenalinum, Adrenocorticotrophin(30X), 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, RNA, Sabadilla, Teucrium scorodonia.


Medication Information

Warnings and Precautions

Warnings

Stop use and consult a physician if symptoms worsen or

persist for more than 7 days.

Indications and Usage

Uses for temporary relief of allergy symptoms commonly experienced in IA, IL, IN, MI, MN, MO, OH, WI: •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. These uses have not been evaluated by the FDA, and product has not been clinically tested.

Dosage and Administration

Directions

█ Initially, depress pump until primed.

█ Spray one dose directly into mouth.

█ Adults: 3 sprays 3 times per day.

█ Children ages 6-12: 2 sprays 3 times per day.

█ Consult a physician for use in children under 6 years of age.

█ Use additionally as needed, up to 6 times per day.

Description

Drug Facts ​__________________________________________________________________________________________________________ HPUS active ingredients: ​Adenosinum cyclophosphoricum, Adrenalinum, Adrenocorticotrophin(30X), 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, RNA, Sabadilla, Teucrium scorodonia.

Section 44425-7

Other information: Tamper resistant for your protection. Use only if safety seal is intact.

Section 50565-1

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.

Section 51727-6

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).

Section 51945-4

Section 53413-1

Questions? Call 866.298.2740

King Bio, Inc. • 3 Westside Drive

Asheville, NC 28806 USA

FDA Reg. #1053442

For latest product information

and instructions, visit

www.DrKings.com

Section 53414-9

If pregnant or breast-feeding, ask a healthcare professional before use.

Section 55105-1

Drug Facts

____________________________________________________________________________________________________________

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, swollen sinuses, lung congestion

Adrenocorticotrophin (30X) ............................congestion, cough

Allium cepa........................hay fever, sinus headache, sneezing

Ambrosia artemisiaefolia......................hay fever, wheezy cough

Chelidonium majus.................mucus in eyes, spasmodic cough

Chenopodium vulvaria.......restlessness, left-side head pressure

Cichorium intybus......................fatigue, headache, eye irritation

Cortisone aceticum.............................allergic reaction, irritability

Euphrasia officinalis.....................discharge from eyes and nose

Galphimia glauca ...............................swollen eyelids, hay fever

Hedera helix .............catarrhal inflammation, cough with sputum

Histaminum hydrochloricum............. coughing fits, itching throat

Juglans cinerea ............red, swollen eyes, sneezing, sore throat

Kali muriaticum....................hoarseness, stuffy nose, nosebleed

Mucosa nasalis suis ..............sinus headache, nasal congestion

Natrum muriaticum...................................watery eyes, sneezing

Pulsatilla........................ pain in head and eyes, mucus in throat

RNA..................................................................allergic reactions

Sabadilla...........................sore throat, runny nose, sneezing fits

Teucrium scorodonia .... .bronchial congestion with much mucus

**“HPUS” indicates the active ingredients are in the official

Homeopathic Pharmacopeia of the United States.



Section 55106-9

Drug Facts​__________________________________________________________________________________________________________

HPUS active ingredients: ​Adenosinum cyclophosphoricum, Adrenalinum, Adrenocorticotrophin(30X), 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, RNA, Sabadilla, Teucrium scorodonia.


Structured Label Content

Indications and Usage (34067-9)

Uses for temporary relief of allergy symptoms commonly experienced in IA, IL, IN, MI, MN, MO, OH, WI: •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. These uses have not been evaluated by the FDA, and product has not been clinically tested.

Dosage and Administration (34068-7)

Directions

█ Initially, depress pump until primed.

█ Spray one dose directly into mouth.

█ Adults: 3 sprays 3 times per day.

█ Children ages 6-12: 2 sprays 3 times per day.

█ Consult a physician for use in children under 6 years of age.

█ Use additionally as needed, up to 6 times per day.

Warnings and Precautions (34071-1)

Warnings

Stop use and consult a physician if symptoms worsen or

persist for more than 7 days.

Section 44425-7 (44425-7)

Other information: Tamper resistant for your protection. Use only if safety seal is intact.

Section 50565-1 (50565-1)

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.

Section 51727-6 (51727-6)

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).

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions? Call 866.298.2740

King Bio, Inc. • 3 Westside Drive

Asheville, NC 28806 USA

FDA Reg. #1053442

For latest product information

and instructions, visit

www.DrKings.com

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a healthcare professional before use.

Section 55105-1 (55105-1)

Drug Facts

____________________________________________________________________________________________________________

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, swollen sinuses, lung congestion

Adrenocorticotrophin (30X) ............................congestion, cough

Allium cepa........................hay fever, sinus headache, sneezing

Ambrosia artemisiaefolia......................hay fever, wheezy cough

Chelidonium majus.................mucus in eyes, spasmodic cough

Chenopodium vulvaria.......restlessness, left-side head pressure

Cichorium intybus......................fatigue, headache, eye irritation

Cortisone aceticum.............................allergic reaction, irritability

Euphrasia officinalis.....................discharge from eyes and nose

Galphimia glauca ...............................swollen eyelids, hay fever

Hedera helix .............catarrhal inflammation, cough with sputum

Histaminum hydrochloricum............. coughing fits, itching throat

Juglans cinerea ............red, swollen eyes, sneezing, sore throat

Kali muriaticum....................hoarseness, stuffy nose, nosebleed

Mucosa nasalis suis ..............sinus headache, nasal congestion

Natrum muriaticum...................................watery eyes, sneezing

Pulsatilla........................ pain in head and eyes, mucus in throat

RNA..................................................................allergic reactions

Sabadilla...........................sore throat, runny nose, sneezing fits

Teucrium scorodonia .... .bronchial congestion with much mucus

**“HPUS” indicates the active ingredients are in the official

Homeopathic Pharmacopeia of the United States.



Section 55106-9 (55106-9)

Drug Facts​__________________________________________________________________________________________________________

HPUS active ingredients: ​Adenosinum cyclophosphoricum, Adrenalinum, Adrenocorticotrophin(30X), 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, RNA, Sabadilla, Teucrium scorodonia.


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