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FDA Approval

911 Adrenal Burnout and Fatigue

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
King Bio Inc.
DUNS: 617901350
Effective Date
May 19, 2025
Labeling Type
HUMAN OTC DRUG LABEL
Acetic acid(10 [hp_X] in 59 mL)
Epinephrine(10 [hp_X] in 59 mL)
Corticotropin(30 [hp_X] in 59 mL)
aesculus hippocastanum flower(10 [hp_X] in 59 mL)
Lipoic acid(10 [hp_X] in 59 mL)
ambergris(10 [hp_X] in 59 mL)
Silver nitrate(10 [hp_X] in 59 mL)
Avena sativa flowering top(10 [hp_X] in 59 mL)
bryonia alba root(10 [hp_X] in 59 mL)
Carbon monoxide(10 [hp_X] in 59 mL)
carpinus betulus flowering top(10 [hp_X] in 59 mL)
Citric acid(10 [hp_X] in 59 mL)
Aprinocarsen(10 [hp_X] in 59 mL)
Fumaric acid(10 [hp_X] in 59 mL)
Calcium sulfide(10 [hp_X] in 59 mL)
sus scrofa hypothalamus(10 [hp_X] in 59 mL)
Dipotassium phosphate(10 [hp_X] in 59 mL)
Sodium chloride(10 [hp_X] in 59 mL)
Phosphoric acid(10 [hp_X] in 59 mL)
sus scrofa pituitary gland, posterior(10 [hp_X] in 59 mL)
Selenious acid(10 [hp_X] in 59 mL)
Silicon dioxide(10 [hp_X] in 59 mL)
Succinic acid(10 [hp_X] in 59 mL)
thyroid, unspecified(10 [hp_X] in 59 mL)
Medicago sativa top(10 [hp_X] in 59 mL)
Herring(10 [hp_X] in 59 mL)
Oxalic Acid(10 [hp_X] in 59 mL)
Gelsemium sempervirens Extract(10 [hp_X] in 59 mL)
D-Lactic acid(10 [hp_X] in 59 mL)
Poly(lactic acid)(10 [hp_X] in 59 mL)
Sepia Extract(10 [hp_X] in 59 mL)

Registrants1

Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.

King Bio Inc.

617901350

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

King Bio Inc.

King Bio Inc.

King Bio Inc.

617901350

Products1

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

911 Adrenal Burnout and Fatigue

Product Details

NDC Product Code
57955-9001
Route of Administration
ORAL
Effective Date
May 19, 2025
Acetic acidActive
Code: Q40Q9N063PClass: ACTIBQuantity: 10 [hp_X] in 59 mL
EpinephrineActive
Code: YKH834O4BHClass: ACTIBQuantity: 10 [hp_X] in 59 mL
CorticotropinActive
Code: K0U68Q2TXAClass: ACTIBQuantity: 30 [hp_X] in 59 mL
aesculus hippocastanum flowerActive
Code: KK0Z92II8MClass: ACTIBQuantity: 10 [hp_X] in 59 mL
Lipoic acidActive
Code: 73Y7P0K73YClass: ACTIBQuantity: 10 [hp_X] in 59 mL
ambergrisActive
Code: XTC0D02P6CClass: ACTIBQuantity: 10 [hp_X] in 59 mL
Silver nitrateActive
Code: 95IT3W8JZEClass: ACTIBQuantity: 10 [hp_X] in 59 mL
Avena sativa flowering topActive
Code: MA9CQJ3F7FClass: ACTIBQuantity: 10 [hp_X] in 59 mL
bryonia alba rootActive
Code: T7J046YI2BClass: ACTIBQuantity: 10 [hp_X] in 59 mL
Carbon monoxideActive
Code: 7U1EE4V452Class: ACTIBQuantity: 10 [hp_X] in 59 mL
carpinus betulus flowering topActive
Code: QOI241B01FClass: ACTIBQuantity: 10 [hp_X] in 59 mL
Citric acidActive
Code: XF417D3PSLClass: ACTIBQuantity: 10 [hp_X] in 59 mL
AprinocarsenActive
Code: FMT95051CQClass: ACTIBQuantity: 10 [hp_X] in 59 mL
Fumaric acidActive
Code: 88XHZ13131Class: ACTIBQuantity: 10 [hp_X] in 59 mL
Calcium sulfideActive
Code: 1MBW07J51QClass: ACTIBQuantity: 10 [hp_X] in 59 mL
sus scrofa hypothalamusActive
Code: N6R0856Z79Class: ACTIBQuantity: 10 [hp_X] in 59 mL
Dipotassium phosphateActive
Code: CI71S98N1ZClass: ACTIBQuantity: 10 [hp_X] in 59 mL
Sodium chlorideActive
Code: 451W47IQ8XClass: ACTIBQuantity: 10 [hp_X] in 59 mL
Phosphoric acidActive
Code: E4GA8884NNClass: ACTIBQuantity: 10 [hp_X] in 59 mL
sus scrofa pituitary gland, posteriorActive
Code: E8S87O660TClass: ACTIBQuantity: 10 [hp_X] in 59 mL
Selenious acidActive
Code: H6241UJ22BClass: ACTIBQuantity: 10 [hp_X] in 59 mL
Silicon dioxideActive
Code: ETJ7Z6XBU4Class: ACTIBQuantity: 10 [hp_X] in 59 mL
Succinic acidActive
Code: AB6MNQ6J6LClass: ACTIBQuantity: 10 [hp_X] in 59 mL
thyroid, unspecifiedActive
Code: 0B4FDL9I6PClass: ACTIBQuantity: 10 [hp_X] in 59 mL
ASCORBIC ACIDInactive
Code: PQ6CK8PD0RClass: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QPClass: IACT
CITRUS AURANTIUM FRUIT OILInactive
Code: 59JDQ5VT0TClass: IACT
ORANGE PEELInactive
Code: TI9T76XD44Class: IACT
CITRUS RETICULATA FRUIT OILInactive
Code: 25P9H3QU5EClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
GLYCERINInactive
Code: PDC6A3C0OXClass: IACT
LACTIC ACID, UNSPECIFIED FORMInactive
Code: 33X04XA5ATClass: IACT
LONICERA JAPONICA FLOWERInactive
Code: 4465L2WS4YClass: IACT
POLYEPSILON-LYSINE (4000 MW)Inactive
Code: WB0M8X4TWRClass: IACT
CARYA OVATA BARKInactive
Code: X765CF609LClass: IACT
STEVIOLInactive
Code: 4741LYX6RTClass: IACT
Medicago sativa topActive
Code: DJO934BRBDClass: ACTIBQuantity: 10 [hp_X] in 59 mL
HerringActive
Code: 51FI676N6FClass: ACTIBQuantity: 10 [hp_X] in 59 mL
Oxalic AcidActive
Code: 0K2L2IJ59OClass: ACTIBQuantity: 10 [hp_X] in 59 mL
Gelsemium sempervirens ExtractActive
Code: 639KR60Q1QClass: ACTIBQuantity: 10 [hp_X] in 59 mL
D-Lactic acidActive
Code: 3B8D35Y7S4Class: ACTIBQuantity: 10 [hp_X] in 59 mL
Poly(lactic acid)Active
Code: F9S9FFU82NClass: ACTIBQuantity: 10 [hp_X] in 59 mL
Sepia ExtractActive
Code: QDL83WN8C2Class: ACTIBQuantity: 10 [hp_X] in 59 mL

Drug Labeling Information

Complete FDA-approved labeling information including indications, dosage, warnings, contraindications, and other essential prescribing details.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image description Frist Aid Mind and Body.jpg

INDICATIONS & USAGE SECTION

Uses

For temporary relief of symptoms due to mental,
emotional, or physical fatigue:

  • nervousness
  • body aches
  • apath
  • weariness
  • confusion
  • irritability
  • indifference
  • lack of focus

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: 911 Adrenal.jpg

DOSAGE & ADMINISTRATION SECTION

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: 911 Adrenal.jpg

WARNINGS SECTION

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: 911 Adrenal.jpg

OTC - ACTIVE INGREDIENT SECTION

Active ingredients

Equal volumes of each HPUS ingredient in 10X, 30X, and 1LM
potencies.

Aceticum acidum, Adrenalinum, Adrenocorticotrophin (30X), Aesculus hippocastanum, flos, Alfalfa, Alpha-lipoicum acidum, Ambra grisea, Argentum nitricum, Avena sativa, Bryonia, Carboneum oxygenisatum, Carpinus betulus, flos, Citricum acidum, DNA, Fumaricum acidum, Gelsemium sempervirens, Hepar sulphuris calcareum, Hypothalamus suis, Kali phosphoricum, Lacticum acidum, Lecithin, Natrum muriaticum, Oxalicum acidum, Phosphoricum acidum, Pituitarum posterium, Sarcolacticum acidum, Selenium metallicum, Sepia, Silicea, Succinicum acidum, Thyroidinum.

Reference image: 911 Adrenal.jpg

OTC - PURPOSE SECTION

Equal volumes of each HPUS ingredient in 10X, 30X, and 1LM
potencies.

Aceticum acidum ..................................debility, Fainting, Paleness
Adrenalinum ............................................... apathy, nervousness
Adrenocorticotrophin (30X) ......................... moody, weak memory
Aesculus hippocastanum, flos .................... mental agitation, worry
Alfalfa .............................................. nervous indigestion, fatigue
Alpha-lipoicum acidum ........................forgetfulness, restless sleep
Ambra grisea ........................................ restlessness, melancholy
Argentum nitricum ....................................................fearfulness
Avena sativa .................................................nervous exhaustion
Bryonia ............................................ lightheaded on standing up
Carboneum oxygenisatum .............. confusion, cerebral congestion
Carpinus betulus, flos ........................... fatigue, mental confusion
Citricum acidum................................................................aches
DNA ..............................................................general well being
Fumaricum acidum ................................................vertigo, sulky
Gelsemium sempervirens........................................ lack of focus
Hepar sulphuris calcareum .............................. physical weakness
Hypothalamus suis ....................... psychological or physical stress
Kali phosphoricum .................................................sluggish mind
Lacticum acidum ........................................................ weakness
Lecithin ...............................................................mental fatigue
Natrum muriaticum ..................................... weakness, weariness
Oxalicum acidum ................................................... neurasthenia
Phosphoricum acidum ............................................. nervousness
Pituitarum posterium ...................................... poor concentration
Sarcolacticum acidum ........................... muscle weakness, fatigue
Selenium metallicum .............................................mental fatigue
Sepia ..........................................absentmindedness, indifference
Silicea ...................................................nervousness, excitability
Succinicum acidum ..................................................nervousness
Thyroidinum................................................ lack of concentration

Reference image: 911 Adrenal.jpg

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

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

Reference image: 911 Adrenal.jpg

OTHER SAFETY INFORMATION

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: 911 Adrenal.jpg

INACTIVE INGREDIENT SECTION

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: 911 Adrenal.jpg

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