FDA.reportPublic FDA data

Headache Tonic

Manufacturer
BioActive Nutritional, Inc. | Apotheca Company
Effective date
2024-10-17
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 02:28:15

Label at a glance#

ProductHeadache Tonic
Active ingredientMILK THISTLE, TANACETUM PARTHENIUM WHOLE, CLAVICEPS PURPUREA SCLEROTIUM, ACONITUM NAPELLUS WHOLE, ATROPA BELLADONNA, BRYONIA ALBA ROOT, GELSEMIUM SEMPERVIRENS ROOT, NITROGLYCERIN, MELILOTUS OFFICINALIS TOP, STRYCHNOS NUX-VOMICA SEED, SEPIA OFFICINALIS JUICE, SPIGELIA ANTHELMIA WHOLE
Label structure9 sections

Dosage and administration

10 drops orally, 3 times a day. Consult a physician for use in children under 12 years of age.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

Carduus Marianus MT, Pyrethrum Parthenium 6X, Secale Cornutum 6X, Aconitum Napellus 12X, Belladonna 12X, Bryonia (Alba) 12X, Gelsemium Sempervirens 12X, Glonoinum 12X, Melilotus Officinalis 12X, Nux Vomica 12X, Sepia 12X, Spigelia Anthelmia 12X.

INDICATIONS:

OTC - PURPOSE SECTION

For temporary relief of throbbing headache with muscular soreness of neck & shoulder pain & fullness, especially in the forehead, occiput and temples, & bursting, splitting headache.

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 cool, dry place.

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

10 drops orally, 3 times a day. Consult a physician for use in children under 12 years of age.

INDICATIONS:

INDICATIONS & USAGE SECTION

For temporary relief of throbbing headache with muscular soreness of neck & shoulder pain & fullness, especially in the forehead, occiput and temples, & bursting, splitting headache.

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

PACKAGE LABEL DISPLAY:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BIOActive Nutritional
HEADACHE TONIC
HOMEOPATHIC
2 FL OZ (60 ml)

Headache TonicHeadache Tonic

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7480e90b-004b-ebe4-2243-4f2fefdd9e78Product name220260128
3f158398-73f2-4b90-47d1-5c60e8719a98Product name920250721
ca6149a6-ded3-9f17-6c41-3e88f2c0c9c0Product name220250117
00358076-c817-430b-b924-11d717dc307cProduct name120160718
669af5aa-14f3-3df7-f100-5f580ffd43c1Product name120140508
6ff3bab7-2dce-8bea-d7ce-54687f0c01fbProduct name120140508
8bb82a1c-d0d0-fc27-011f-172e545f0382Product name120140508
cb03406d-e223-80bb-67d8-be80f9b6a4f2Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43857-0507-12024-10-17C16284748780-1ba0f9c33-1cf1-a910-e053-dadaa90a0b85DRUG FACTS:
43857-0507-12021-01-29C16284748780-1ba0f9c33-1cf1-a910-e053-dadaa90a0b85DRUG FACTS:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43857-0507-1Headache Tonic60 mL in 1 BOTTLE, DROPPERLIQUID604

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43857-0507HEADACHE TONIC (CARDUUS MARIANUS, PYRETHRUM PARTHENIUM, SECALE CORNUTUM, ACONITUM NAPELLUS, BELLADONNA, BRYONIA (ALBA), GELSEMIUM SEMPERVIRENS, GLONOINUM, MELILOTUS OFFICINALIS, NUX VOMICA, SEPIA, SPIGELIA ANTHELMIA) LIQUID [BIOACTIVE NUTRITIONAL, INC.]4Current NDC, Legacy NDC, 1 package rows20241019_a6526cc4-028b-45df-ac1f-c3cec7556e93.zip

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
43857-050743857-0507-1

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
MILK THISTLEU946SH95EEACTIB
TANACETUM PARTHENIUM WHOLE6GE7Z0761KACTIB
CLAVICEPS PURPUREA SCLEROTIUM01G9XEA93NACTIB
ACONITUM NAPELLUS WHOLEU0NQ8555JDACTIB
ATROPA BELLADONNAWQZ3G9PF0HACTIB
BRYONIA ALBA ROOTT7J046YI2BACTIB
GELSEMIUM SEMPERVIRENS ROOT639KR60Q1QACTIB
NITROGLYCERING59M7S0WS3ACTIB
MELILOTUS OFFICINALIS TOPGM6P02J2DXACTIB
STRYCHNOS NUX-VOMICA SEED269XH13919ACTIB
SEPIA OFFICINALIS JUICEQDL83WN8C2ACTIB
SPIGELIA ANTHELMIA WHOLEWYT05213GEACTIB
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
Headache TonicCARDUUS MARIANUS, PYRETHRUM PARTHENIUM, SECALE CORNUTUM, ACONITUM NAPELLUS, BELLADONNA, BRYONIA (ALBA), GELSEMIUM SEMPERVIRENS, GLONOINUM, MELILOTUS OFFICINALIS, NUX VOMICA, SEPIA, SPIGELIA ANTHELMIABioActive Nutritional, Inc.a6526cc4-028b-45df-ac1f-c3cec7556e932024-10-17WarningsExact identifier
ndc (package): 43857-0507-1
ndc (product): 43857-0507
ndc11 (package): 43857050701
spl id: f4d7a7e3-3951-444e-a65e-78aebe52c7c9
spl set id: a6526cc4-028b-45df-ac1f-c3cec7556e93

Reported adverse events (FAERS/openFDA)#

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