Aconitum napellus
- Manufacturer
- Historical Remedies | Newton Laboratories, Inc.
- Effective date
- 2025-10-07
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 9
- Source
- full-release
- Hydrated at
- 2026-06-01 02:37:20
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
INDICATIONS & USAGE SECTION
Formulated for susceptibility to colds.
DOSAGE & ADMINISTRATION SECTION
Directions: Adults4 pellets; Children(4-12 years) 2 pellets; Dissolve under the tongue. Take every half hour as needed, or 4 times a day.
OTC - ACTIVE INGREDIENT SECTION
1% Aconitum napellus 12x
OTC - PURPOSE SECTION
Formulated for susceptibility to colds.
INACTIVE INGREDIENT SECTION
Inactive Ingredients: Organic beet-derived sucrose; gluten-free, lactose-free, non-GMO
QUESTIONS SECTION
Distributed by Historical Remedies; 122 S Wabasha, Saint Paul, MN 55107; 800-676-6654
WARNINGS SECTION
Warning: Consult a doctor if symptoms persist more than 3 days or worsen. If pregnant or nursing, ask a doctor before use. Keep out of reach of children. Do not use if tamper-evident band is missing or broken.
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast-feeding,ask a doctor before use.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children.
PACKAGE LABEL
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 57556-010-02 | Aconitum napellus | 14 g in 1 BOTTLE, GLASS | PELLET | 14 | 9 |
Products#
Every source-derived product name is available through these pages.
- Aconitum napellus
- Aconite
- SUCROSE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 57556-010 | 57556-010-02 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| SUCROSE | C151H8M554 | IACT |
| ACONITUM NAPELLUS | U0NQ8555JD | ACTIB |
Source Document#
Older Hydrated Versions#
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 8 | 2024-10-31 | full-release | 2026-06-01 02:28:46 |
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 |
|---|---|---|---|---|---|---|
| Aconitum napellus | ACONITE | Historical Remedies | c67753ee-08d9-a2fc-e053-2995a90aab99 | 2025-10-07 | Warnings | 57556-010-02 57556-010 57556001002 4093b43a-691c-57cf-e063-6294a90adedc c67753ee-08d9-a2fc-e053-2995a90aab99 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
