Dosage and administration
10 drops orally, 3 times a day. Consult a physician for use in children under 12 years of age.
DRUG FACTS:
- Manufacturer
- BioActive Nutritionals, Inc. | Apotheca Company
- Effective date
- 2026-07-30
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 4
- Source
- daily-update
- Hydrated at
- 2026-08-04 03:32:24
Label at a glance#
ProductHeadache
Active ingredientMELILOTUS OFFICINALIS TOP, SPIGELIA ANTHELMIA WHOLE, ONION, ATROPA BELLADONNA, BRYONIA ALBA ROOT, BLACK COHOSH, GELSEMIUM SEMPERVIRENS ROOT, NITROGLYCERIN, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, STRYCHNOS NUX-VOMICA SEED, SANGUINARIA CANADENSIS ROOT, SILICON DIOXIDE, CITHARACANTHUS SPINICRUS
Label structure9 sections
Label contents#
Full prescribing information#
ACTIVE INGREDIENTS:
Melilotus Officinalis 3X, Spigelia Anthelmia 6X, Allium Cepa 12X, Belladonna 12X, Bryonia (Alba) 12X, Cimicifuga Racemosa 12X, Gelsemium Sempervirens 12X, Glonoinum 12X, Magnesia Phosphorica 12X, Nux Vomica 12X, Sanguinaria Canadensis 12X, Silicea 12X, Tarentula Cubensis 12X.
INDICATIONS:
For temporary relief of headache with muscular soreness of neck and shoulders, heaviness of the head, fullness all over the head, pain as if a band around the head.
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.
KEEP OUT OF REACH OF CHILDREN:
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
DIRECTIONS:
10 drops orally, 3 times a day. Consult a physician for use in children under 12 years of age.
INDICATIONS:
For temporary relief of headache with muscular soreness of neck and shoulders, heaviness of the head, fullness all over the head, pain as if a band around the head.
INACTIVE INGREDIENTS:
Demineralized Water, 25% Ethanol
QUESTIONS:
Distributed by:
BioActive Nutritional, Inc.
1803 N. Wickham Rd.
Melbourne, FL 32935
bioactivenutritional.com
PACKAGE LABEL DISPLAY:
BIOActive Nutritional
HEADACHE
HOMEOPATHIC
1 FL OZ (30 ml)
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 43857-0488-1 | 2024-10-17 | C162847 | 48780-1 | f386c649-c572-0266-e053-dadaa90a7c1a | DRUG FACTS: |
| 43857-0488-1 | 2024-10-17 | C162847 | 48780-1 | f386c649-c572-0266-e053-dadaa90a7c1a | DRUG FACTS: |
| 43857-0488-1 | 2023-01-30 | C162847 | 48780-1 | f386c649-c572-0266-e053-dadaa90a7c1a | DRUG FACTS: |
| 43857-0488-1 | 2023-01-30 | C162847 | 48780-1 | f386c649-c572-0266-e053-dadaa90a7c1a | DRUG FACTS: |
Products#
Every source-derived product name is available through these pages.
- Headache
- Melilotus Officinalis, Spigelia Anthelmia, Allium Cepa, Belladonna, Bryonia (Alba), Cimicifuga Racemosa, Gelsemium Sempervirens, Glonoinum, Magnesia Phosphorica, Nux Vomica, Sanguinaria Canadensis, Silicea, Tarentula Cubensis
- MELILOTUS OFFICINALIS TOP
- SPIGELIA ANTHELMIA WHOLE
- SPIGELIA ANTHELMIA
- ONION
- ATROPA BELLADONNA
- BRYONIA ALBA ROOT
- BLACK COHOSH
- GELSEMIUM SEMPERVIRENS ROOT
- NITROGLYCERIN
- MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE
- MAGNESIUM CATION
- STRYCHNOS NUX-VOMICA SEED
- SANGUINARIA CANADENSIS ROOT
- SILICON DIOXIDE
- CITHARACANTHUS SPINICRUS
- WATER
- ALCOHOL
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 43857-0488 | 43857-0488-1 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
Older Hydrated Versions#
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 3 | 2024-10-17 | full-release | 2026-06-01 02:28:15 |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 680758cc-92ab-4a72-a63d-0de27bf783c4 | 918bc478-78a2-41e1-b123-f5350cf8f43a | 2026-07-30 | Warnings | 680758cc-92ab-4a72-a63d-0de27bf783c4 918bc478-78a2-41e1-b123-f5350cf8f43a |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.