FDA.reportPublic FDA data

3 Acute Stress

Manufacturer
Biotics Research Corporation | Apotheca Company
Effective date
2024-10-18
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 20:51:53

Label at a glance#

Product3 Acute Stress
Active ingredientARNICA MONTANA WHOLE, BELLIS PERENNIS WHOLE, PASSIFLORA INCARNATA FLOWERING TOP, VALERIAN, ARSENIC TRIOXIDE, APIS MELLIFERA, HUMAN BREAST TUMOR CELL, HELIANTHEMUM CANADENSE, CLEMATIS RECTA FLOWERING TOP, ARABICA COFFEE BEAN, STRYCHNOS IGNATII SEED, LACHESIS MUTA VENOM, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, SODIUM CHLORIDE, SODIUM SULFATE, ORNITHOGALUM UMBELLATUM WHOLE, PHOSPHORIC ACID, SALIX NIGRA BARK, DELPHINIUM STAPHISAGRIA SEED
Label structure9 sections

Dosage and administration

One (1) teaspoon twice daily or as otherwise directed by a healthcare professional. Consult a physician for use in children under 6 years of age.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

Arnica Montana 3X, 30C, Bellis Perennis 3X, 30C, Passiflora Incarnata 3X, 30C, Valeriana Officinalis 3X, 30C, Arsenicum Album 6X, 30C, Apis Mellifica 30C, Carcinosin 30C, Cistus Canadensis 30C, Clematis Erecta 30C, Coffea Cruda 30C, Ignatia Amara 30C, Lachesis Mutus 30C, Magnesia Phosphorica 30C, Natrum Muriaticum 30C, Natrum Sulphuricum 30C, Ornithogalum Umbellatum 30C, Phosphoricum Acidum 30C, Salix Nigra 30C, Staphysagria 30C.

INDICATIONS:

OTC - PURPOSE SECTION

For temporary relief of acute stress due to emotional strain, anxiety, sleeplessness, apprehension or fear.

WARNINGS:

WARNINGS SECTION

If symptoms persist or worsen, seek the advice of a healthcare professional.

Caution: Not recommended for pregnant or lactating women.

KEEP OUT OF REACH OF CHILDREN

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

Tamper Seal: Sealed for your protection with a clear, full body seal. Do not use if seal is missing or broken.

KEEP OUT OF REACH OF CHILDREN:

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 right away.

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

One (1) teaspoon twice daily or as otherwise directed by a healthcare professional.
Consult a physician for use in children under 6 years of age.

INDICATIONS:

INDICATIONS & USAGE SECTION

For temporary relief of acute stress due to emotional strain, anxiety, sleeplessness, apprehension or fear.

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

Citric Acid, Demineralized Water, Ethanol 1.65%, Sodium Benzoate.

QUESTIONS:

OTC - QUESTIONS SECTION

Distributed by

Biotics Research Corporation

Rosenberg, TX 77471 • (281) 344-0909

PACKAGE LABEL DISPLAY:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Biotics Research Corporation's

21ST CENTURY
HOMEOPATHICS
NDC# 55146-003-01

HOMEOPATHIC REMEDY

#3
Acute Stress

Water Based
Formula

4 fl. oz.
(120 ml)

#3 Acute Stress#3 Acute Stress

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55146-003-012024-10-18C16284748780-1ba0f9c33-3c3c-a910-e053-dadaa90a0b85Drug Facts:
55146-003-012021-01-29C16284748780-1ba0f9c33-3c3c-a910-e053-dadaa90a0b85Drug Facts:

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55146-0033 ACUTE STRESS (ARNICA MONTANA, BELLIS PERENNIS, PASSIFLORA INCARNATA, VALERIANA OFFICINALIS, ARSENICUM ALBUM, APIS MELLIFICA, CARCINOSIN, CISTUS CANADENSIS, CLEMATIS ERECTA, COFFEA CRUDA, IGNATIA AMARA, LACHESIS MUTUS, MAGNESIA PHOSPHORICA, NATRUM MURIATICUM, NATRUM SULPHURICUM, ORNITHOGALUM UMBELLATUM, PHOSPHORICUM ACIDUM, SALIX NIGRA, STAPHYSAGRIA) LIQUID [BIOTICS RESEARCH CORPORATION]4Legacy NDC20241020_6bd54609-f453-41d6-a076-037c608d3b0a.zip

Products#

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

DailyMed product names page 1 of 1 · 31 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55146-00355146-003-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 23 matching rows.

Name, UNII, Kind table
NameUNIIKind
ARNICA MONTANA WHOLEO80TY208ZWACTIB
BELLIS PERENNIS WHOLE2HU33I03UYACTIB
PASSIFLORA INCARNATA FLOWERING TOPCLF5YFS11OACTIB
VALERIANJWF5YAW3QWACTIB
ARSENIC TRIOXIDES7V92P67HOACTIB
APIS MELLIFERA7S82P3R43ZACTIB
HUMAN BREAST TUMOR CELLC62OO7VD9KACTIB
HELIANTHEMUM CANADENSE46G3W789Q3ACTIB
CLEMATIS RECTA FLOWERING TOP396421SP9FACTIB
ARABICA COFFEE BEAN3SW678MX72ACTIB
STRYCHNOS IGNATII SEED1NM3M2487KACTIB
LACHESIS MUTA VENOMVSW71SS07IACTIB
MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATEHF539G9L3QACTIB
SODIUM CHLORIDE451W47IQ8XACTIB
SODIUM SULFATE0YPR65R21JACTIB
ORNITHOGALUM UMBELLATUM WHOLE9NS3M2Y78SACTIB
PHOSPHORIC ACIDE4GA8884NNACTIB
SALIX NIGRA BARKQU52J3A5B3ACTIB
DELPHINIUM STAPHISAGRIA SEED00543AP1JVACTIB
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
SODIUM BENZOATEOJ245FE5EUIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT

Source Document#

Source XML

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
4d964d52-0168-4b6a-bfb9-7b611ecd16516bd54609-f453-41d6-a076-037c608d3b0a2024-10-18WarningsExact identifier
spl id: 4d964d52-0168-4b6a-bfb9-7b611ecd1651
spl set id: 6bd54609-f453-41d6-a076-037c608d3b0a

Reported adverse events (FAERS/openFDA)#

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