MedPath

Adrenal Tonic

DRUG FACTS:

Approved
Approval ID

2bbf65e2-47b9-46d3-a8de-69bc543783f8

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 20, 2025

Manufacturers
FDA

BioActive Nutritional, Inc.

DUNS: 624980496

Products 1

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

Aralia Quinquefolia, Glycyrrhiza Glabra, Sarsaparilla, Avena Sativa, Glandula Suprarenalis Bovine, Adrenalinum, Arsenicum Album, Kali Phosphoricum, Natrum Muriaticum, Nux Vomica, Phosphoricum Acidum, Veratrum Album

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code43857-0057
Product Classification
G
Generic Name
Aralia Quinquefolia, Glycyrrhiza Glabra, Sarsaparilla, Avena Sativa, Glandula Suprarenalis Bovine, Adrenalinum, Arsenicum Album, Kali Phosphoricum, Natrum Muriaticum, Nux Vomica, Phosphoricum Acidum, Veratrum Album
Product Specifications
Route of AdministrationORAL
Effective DateMay 20, 2025
FDA Product Classification

INGREDIENTS (14)

AMERICAN GINSENGActive
Quantity: 1 [hp_X] in 1 mL
Code: 8W75VCV53Q
Classification: ACTIB
GLYCYRRHIZA GLABRAActive
Quantity: 1 [hp_X] in 1 mL
Code: 2788Z9758H
Classification: ACTIB
SMILAX ORNATA ROOTActive
Quantity: 1 [hp_X] in 1 mL
Code: 2H1576D5WG
Classification: ACTIB
AVENA SATIVA FLOWERING TOPActive
Quantity: 3 [hp_X] in 1 mL
Code: MA9CQJ3F7F
Classification: ACTIB
BOS TAURUS ADRENAL GLANDActive
Quantity: 8 [hp_X] in 1 mL
Code: M2776SWB29
Classification: ACTIB
EPINEPHRINEActive
Quantity: 12 [hp_X] in 1 mL
Code: YKH834O4BH
Classification: ACTIB
ARSENIC TRIOXIDEActive
Quantity: 12 [hp_X] in 1 mL
Code: S7V92P67HO
Classification: ACTIB
POTASSIUM PHOSPHATE, DIBASICActive
Quantity: 12 [hp_X] in 1 mL
Code: CI71S98N1Z
Classification: ACTIB
SODIUM CHLORIDEActive
Quantity: 12 [hp_X] in 1 mL
Code: 451W47IQ8X
Classification: ACTIB
PHOSPHORIC ACIDActive
Quantity: 12 [hp_X] in 1 mL
Code: E4GA8884NN
Classification: ACTIB
VERATRUM ALBUM ROOTActive
Quantity: 12 [hp_X] in 1 mL
Code: QNS6W5US1Z
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
STRYCHNOS NUX-VOMICA SEEDActive
Quantity: 12 [hp_X] in 1 mL
Code: 269XH13919
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 5/20/2025

PACKAGE LABEL DISPLAY:

BIOActiveNutritional

ADRENAL TONIC

HOMEOPATHIC

** 2 fl. oz. (60mL)**

ADRENAL TONIC

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 5/20/2025

USES:

For temporary relief of marked debility producing nervous exhaustion, weakness and exhaustion following acute illness; and rheumatic pains in the sacrum and joints with muscular weakness.**

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 5/20/2025

ACTIVE INGREDIENTS:

Adrenalinum 12X, 30X, Aralia Quinquefolia MT, Arsenicum Album 12X, Avena Sativa 3X, Glandula Suprarenalis Bovine 8X, Glycyrrhiza Glabra MT, Kali Phosphoricum 12X, Natrum Muriaticum 12X, Nux Vomica 12X, Phosphoricum Acidum 12X, Sarsaparilla MT, 12X, Veratrum Album 12X.

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 5/20/2025

PURPOSE:

Adrenalinum - fatigue,** Aralia Quinquefolia - rheumatism,** Arsenicum Album - weakness,** Avena Sativa – nervous exhaustion,** Glandula Suprarenalis Bovine – adrenal support,** Glycyrrhiza Glabra – adrenal support,** Kali Phosphoricum

  • headache,** Natrum Muriaticum - fatigue,** Nux Vomica - restlessness,** Phosphoricum Acidum – Acidum debility,** Sarsaparilla – minor injury,** Veratrum Album – weakness**

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

WARNINGS SECTION

LOINC: 34071-1Updated: 5/20/2025

WARNINGS:

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

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

Do not use if tamper evident seal is broken or missing.

Store in a cool, dry place.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 5/20/2025

KEEP OUT OF REACH OF CHILDREN:

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

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 5/20/2025

DIRECTIONS:

• 10 drops orally, 3 times a day.

• Consult a health care professional for use in children under 12 years of age.

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 5/20/2025

INACTIVE INGREDIENTS:

Demineralized Water, 25% Ethanol

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 5/20/2025

QUESTIONS:

Distributed by:

BioActive Nutritional, Inc.

1803 N. Wickham Rd.

Melbourne, FL 32935

bioactivenutritional.com

1-800-288-9525

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Adrenal Tonic - FDA Drug Approval Details