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Regional Allergies Southern U.S.

Regional Allergies Southern U.S.

Approved
Approval ID

2d98d4e3-c988-4f25-a9c0-6ff6024832e5

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 20, 2025

Manufacturers
FDA

King Bio Inc.

DUNS: 617901350

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Adenosinum cyclophosphoricum, Adrenalinum, Adrenocorticotrophin, Allium cepa, Alnus serrulata, Arum triphyllum, Arundo mauritanica, Carduus benedictus, Cichorium intybus, Cortisone aceticum, Dolichos pruriens, Euphrasia officinalis, Galphimia glauca, Histaminum hydrochloricum, Juglans cinerea, Kali muriaticum, Nasturtium aquaticum, Natrum muriaticum, Rhus tox, RNA, Sabadilla, Sassafras officinale.

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code57955-0762
Product Classification
G
Generic Name
Adenosinum cyclophosphoricum, Adrenalinum, Adrenocorticotrophin, Allium cepa, Alnus serrulata, Arum triphyllum, Arundo mauritanica, Carduus benedictus, Cichorium intybus, Cortisone aceticum, Dolichos pruriens, Euphrasia officinalis, Galphimia glauca, Histaminum hydrochloricum, Juglans cinerea, Kali muriaticum, Nasturtium aquaticum, Natrum muriaticum, Rhus tox, RNA, Sabadilla, Sassafras officinale.
Product Specifications
Route of AdministrationORAL
Effective DateMay 20, 2025
FDA Product Classification

INGREDIENTS (34)

EPINEPHRINEActive
Quantity: 12 [hp_X] in 59 mL
Code: YKH834O4BH
Classification: ACTIB
CORTICOTROPINActive
Quantity: 30 [hp_X] in 59 mL
Code: K0U68Q2TXA
Classification: ACTIB
ONIONActive
Quantity: 12 [hp_X] in 59 mL
Code: 492225Q21H
Classification: ACTIB
ALNUS SERRULATA BARKActive
Quantity: 12 [hp_X] in 59 mL
Code: BQ5P19J9OL
Classification: ACTIB
ARISAEMA TRIPHYLLUM ROOTActive
Quantity: 12 [hp_X] in 59 mL
Code: DM64K844DM
Classification: ACTIB
ARUNDO PLINIANA ROOTActive
Quantity: 12 [hp_X] in 59 mL
Code: ZXE7LB03WC
Classification: ACTIB
CENTAUREA BENEDICTAActive
Quantity: 12 [hp_X] in 59 mL
Code: 6L5ZL09795
Classification: ACTIB
CORTISONE ACETATEActive
Quantity: 12 [hp_X] in 59 mL
Code: 883WKN7W8X
Classification: ACTIB
EUPHRASIA STRICTAActive
Quantity: 12 [hp_X] in 59 mL
Code: C9642I91WL
Classification: ACTIB
GALPHIMIA GLAUCA FLOWERING TOPActive
Quantity: 12 [hp_X] in 59 mL
Code: 93PH5Q8M7E
Classification: ACTIB
HISTAMINE DIHYDROCHLORIDEActive
Quantity: 12 [hp_X] in 59 mL
Code: 3POA0Q644U
Classification: ACTIB
JUGLANS CINEREA BRANCH BARK/ROOT BARKActive
Quantity: 12 [hp_X] in 59 mL
Code: 48FZ1BHO18
Classification: ACTIB
POTASSIUM CHLORIDEActive
Quantity: 12 [hp_X] in 59 mL
Code: 660YQ98I10
Classification: ACTIM
NASTURTIUM OFFICINALEActive
Quantity: 12 [hp_X] in 59 mL
Code: YH89GMV676
Classification: ACTIB
SODIUM CHLORIDEActive
Quantity: 12 [hp_X] in 59 mL
Code: 451W47IQ8X
Classification: ACTIB
TOXICODENDRON PUBESCENS LEAFActive
Quantity: 12 [hp_X] in 59 mL
Code: 6IO182RP7A
Classification: ACTIB
SCHOENOCAULON OFFICINALE SEEDActive
Quantity: 12 [hp_X] in 59 mL
Code: 6NAF1689IO
Classification: ACTIB
SASSAFRAS ALBIDUM ROOT BARKActive
Quantity: 12 [hp_X] in 59 mL
Code: XC5UMP9I5F
Classification: ACTIB
ASCORBIC ACIDInactive
Code: PQ6CK8PD0R
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
CITRUS AURANTIUM FRUIT OILInactive
Code: 59JDQ5VT0T
Classification: IACT
ORANGE PEELInactive
Code: TI9T76XD44
Classification: IACT
CITRUS RETICULATA FRUIT OILInactive
Code: 25P9H3QU5E
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
LACTIC ACID, UNSPECIFIED FORMInactive
Code: 33X04XA5AT
Classification: IACT
LONICERA JAPONICA FLOWERInactive
Code: 4465L2WS4Y
Classification: IACT
POLYEPSILON-LYSINE (4000 MW)Inactive
Code: WB0M8X4TWR
Classification: IACT
CARYA OVATA BARKInactive
Code: X765CF609L
Classification: IACT
STEVIOLInactive
Code: 4741LYX6RT
Classification: IACT
ADENOSINE CYCLIC PHOSPHATEActive
Quantity: 12 [hp_X] in 59 mL
Code: E0399OZS9N
Classification: ACTIB
CHICORY ROOTActive
Quantity: 12 [hp_X] in 59 mL
Code: 090CTY533N
Classification: ACTIB
MUCUNA PRURIENS FRUIT TRICHOMEActive
Quantity: 12 [hp_X] in 59 mL
Code: 3E271BSI0C
Classification: ACTIB
SACCHAROMYCES CEREVISIAE RNAActive
Quantity: 12 [hp_X] in 59 mL
Code: J17GBZ5VGX
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 12/12/2022

image description

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 12/12/2022

Uses

Uses for temporary relief of allergy symptomse commonly
experienced in AL, AR, DC, DE, FL, GA, KY, LA, MD, MS, NC,
SC, TN, VA, WV:

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.

Reference image:Southern U.S.jpg

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 12/12/2022

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.

Reference image:Southern U.S.jpg

OTHER SAFETY INFORMATION

LOINC: 60561-8Updated: 12/12/2022

Other information

Tamper resistant for your protection.

Use only if safety seal is intact.

Keep carton for complete drug facts and product information.

Questions? Call 866.298.2740

King Bio, Inc. 3 Westside Drive

Asheville, NC 2806 USA

FDA Reg. #1053442

For latest product information and instructions: www.DrKings.com

Reference image:Southern U.S.jpg

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 12/12/2022

Inactive Ingredients

Citrus Extract (ascorbic acid, citric acid, citrus aurantium amara fruit extract, citrus aurantium sinensis peel extract, citrus reticulata fruit extact, demineralized water, glycerin, lactic acid), Honeysuckle (Lonicera japonica), Polylysine, Purified Water, Shagbark Hickory (Carya Ovata) Bark Extract, Steviol (Steviol Glycosides).

Reference image:Southern U.S.jpg

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 12/12/2022

Active ingredients

Equal volumes of each HPUS** ingredient in 12X, 30X, and 1LM
potencies unless otherwise noted.

Adenosinum cyclophosphoricum, Adrenalinum, Adrenocorticotrophin, Allium cepa, Alnus serrulata, Arum triphyllum, Arundo mauritanica, Carduus benedictus, Cichorium intybus, Cortisone aceticum, Dolichos pruriens, Euphrasia officinalis, Galphimia glauca, Histaminum hydrochloricum, Juglans cinerea, Kali muriaticum, Nasturtium aquaticum, Natrum muriaticum, Rhus tox, RNA, Sabadilla, Sassafras officinale.

HPUS indicates the active ingredients are in the official Homeopathic Pharmacopeia of the United States.

Reference image:Southern U.S.jpg

WARNINGS SECTION

LOINC: 34071-1Updated: 12/12/2022

Warnings

Stop use and consult a physician if symptoms worsen or
persist for more than 7 days.

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

Keep out of reach of children.

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

Reference image:Southern U.S.jpg

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 12/12/2022

Keep out of reach of children.

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

Reference image:Southern U.S.jpg

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 12/12/2022

Active ingredients Purpose †

Equal volumes of each HPUS** ingredient in 12X, 30X, and 1LM
potencies.

Adenosinum cyclophosphoricum................headache, runny nose
Adrenalinum ..............hay fever, swollen sinuses, lung congestion
Adrenocorticotrophin (30X) ............................congestion, cough
Allium cepa...........................hay fever, sinus headache, sneezing
Alnus serrulata ..........................................hay fever, bronchitis
Arum triphyllum ............inflammation of nasal mucus membranes
Arundo mauritanica .........................nasal congestion and itching
Carduus benedictus ............................................tickling in nose
Cichorium intybus...........................................fatigue, headache
Cortisone aceticum.............................allergic reaction, irritability
Dolichos pruriens.......................................sore throat, itchy skin
Euphrasia officinalis.........................discharge from eyes and nose
Galphimia glauca.................................... puffy eyelids, hay fever
Histaminum hydrochloricum ....................coughing, itching throat
Juglans cinerea ............................red eyes, sneezing, sore throat
Kali muriaticum.......................................hoarseness, stuffy nose
Nasturtium aquaticum ......................sensitivity to cigarette toxins
Natrum muriaticum ...................................watery eyes, sneezing
Rhus tox .............................dry cough, sneezing, swelling of nose
RNA................................................................allergic reactions
Sabadilla..................................sore throat, runny nose, sneezing
Sassafras officinale .............................. minor breathing difficulty

**“HPUS” indicates the active ingredients are in the official
Homeopathic Pharmacopeia of the United States.

Reference image:Southern U.S.jpg

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