Adrenal Tonic

Manufacturer
BioActive Nutritional, Inc. | Apotheca Company
Effective date
2025-05-20
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 02:33:36

Label at a glance#

ProductAdrenal Tonic
Active ingredientAMERICAN GINSENG, GLYCYRRHIZA GLABRA, SMILAX ORNATA ROOT, AVENA SATIVA FLOWERING TOP, BOS TAURUS ADRENAL GLAND, EPINEPHRINE, ARSENIC TRIOXIDE, POTASSIUM PHOSPHATE, DIBASIC, SODIUM CHLORIDE, STRYCHNOS NUX-VOMICA SEED, PHOSPHORIC ACID, VERATRUM ALBUM ROOT
Label structure9 sections

Indications and 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.

Dosage and administration

• 10 drops orally, 3 times a day. • Consult a health care professional for use in children under 12 years of age.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

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.

PURPOSE:

OTC - PURPOSE SECTION

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.

USES:

INDICATIONS & USAGE SECTION

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.

WARNINGS:

WARNINGS SECTION

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.

KEEP OUT OF REACH OF CHILDREN:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

• 10 drops orally, 3 times a day.

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

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

Demineralized Water, 25% Ethanol

QUESTIONS:

OTC - QUESTIONS SECTION

Distributed by:

BioActive Nutritional, Inc.

1803 N. Wickham Rd.

Melbourne, FL 32935

bioactivenutritional.com

1-800-288-9525

PACKAGE LABEL DISPLAY:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BIOActive Nutritional

ADRENAL TONIC

HOMEOPATHIC

 2 fl. oz. (60mL)

ADRENAL TONICADRENAL TONIC

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43857-0057-12023-06-05C16284748780-19d75b9d0-6cf1-f424-e053-dadaa90a57ceDRUG FACTS:
43857-0057-12020-01-31C16284748780-19d75b9d0-6cf1-f424-e053-dadaa90a57ceDRUG FACTS:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43857-0057-1Adrenal Tonic60 mL in 1 BOTTLE, DROPPERLIQUID604

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43857-0057ADRENAL TONIC (ARALIA QUINQUEFOLIA, GLYCYRRHIZA GLABRA, SARSAPARILLA, AVENA SATIVA, GLANDULA SUPRARENALIS BOVINE, ADRENALINUM, ARSENICUM ALBUM, KALI PHOSPHORICUM, NATRUM MURIATICUM, NUX VOMICA, PHOSPHORICUM ACIDUM, VERATRUM ALBUM) LIQUID [BIOACTIVE NUTRITIONAL, INC.]4Current NDC, Legacy NDC, 1 package rows20250522_2bbf65e2-47b9-46d3-a8de-69bc543783f8.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
AMERICAN GINSENGACTIVE INGREDIENT8W75VCV53Q1
ARSENIC TRIOXIDEACTIVE INGREDIENTS7V92P67HO1
AVENA SATIVA FLOWERING TOPACTIVE INGREDIENTMA9CQJ3F7F1
BOS TAURUS ADRENAL GLANDACTIVE INGREDIENTM2776SWB291
EPINEPHRINEACTIVE INGREDIENTYKH834O4BH1
GLYCYRRHIZA GLABRAACTIVE INGREDIENT2788Z9758H1
PHOSPHORIC ACIDACTIVE INGREDIENTE4GA8884NN1
POTASSIUM PHOSPHATE, DIBASICACTIVE INGREDIENTCI71S98N1Z1
SMILAX REGELII ROOTACTIVE INGREDIENT2H1576D5WG1
SODIUM CHLORIDEACTIVE INGREDIENT451W47IQ8X1
STRYCHNOS NUX-VOMICA SEEDACTIVE INGREDIENT269XH139191
VERATRUM ALBUM ROOTACTIVE INGREDIENTQNS6W5US1Z1
AMERICAN GINSENGACTIVE MOIETY8W75VCV53Q1
ARSENIC CATION (3+)ACTIVE MOIETYC96613F5AV1
AVENA SATIVA FLOWERING TOPACTIVE MOIETYMA9CQJ3F7F1
BOS TAURUS ADRENAL GLANDACTIVE MOIETYM2776SWB291
CHLORIDE IONACTIVE MOIETYQ32ZN486981
EPINEPHRINEACTIVE MOIETYYKH834O4BH1
GLYCYRRHIZA GLABRAACTIVE MOIETY2788Z9758H1
PHOSPHATE IONACTIVE MOIETYNK08V8K8HR1
PHOSPHORIC ACIDACTIVE MOIETYE4GA8884NN1
SARSAPARILLAACTIVE MOIETY2H1576D5WG1
STRYCHNOS NUX-VOMICA SEEDACTIVE MOIETY269XH139191
VERATRUM ALBUM ROOTACTIVE MOIETYQNS6W5US1Z1
ALCOHOLINACTIVE INGREDIENT3K9958V90M1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43857-005743857-0057-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 2 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
ALCOHOLALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Adrenal TonicARALIA QUINQUEFOLIA, GLYCYRRHIZA GLABRA, SARSAPARILLA, AVENA SATIVA, GLANDULA SUPRARENALIS BOVINE, ADRENALINUM, ARSENICUM ALBUM, KALI PHOSPHORICUM, NATRUM MURIATICUM, NUX VOMICA, PHOSPHORICUM ACIDUM, VERATRUM ALBUMBioActive Nutritional, Inc.2bbf65e2-47b9-46d3-a8de-69bc543783f82025-05-20WarningsExact identifier
ndc (package): 43857-0057-1
ndc (product): 43857-0057
ndc11 (package): 43857005701
spl id: f59b92f7-2eea-41ea-ae7b-0efde6b7b25e
spl set id: 2bbf65e2-47b9-46d3-a8de-69bc543783f8

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.