Aconitum napellus

Manufacturer
Boiron | Boiron, Inc.
Effective date
2025-09-10
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 02:35:00

Label at a glance#

ProductAconitum napellus
Active ingredientACONITUM NAPELLUS
Label structure11 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient** (in each pellet)

Aconitum napellus 30C HPUS (**contains 0.443 mg of the active ingredient in each pellet)

(contains less than 10 -12 mg aconitine alkaloids)

The letters "HPUS" indicate that the component in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.

OTC - PURPOSE SECTION

Purpose*

Relieves high fever (up to 102 oF) of sudden onset with dry skin*

INDICATIONS & USAGE SECTION

Uses*

Temporarily relieves symptoms of high fever (up to 102 oF) of sudden onset with

  • dry, hot, and red skin
  • cough
  • restlessness
  • agitation

OTC - STOP USE SECTION

Stop use and ask a doctor if symptoms persist for more than 3 days, worsen, or new symptoms occur because these could be signs of a serious condition.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Adults and children: At the onset of symptoms, dissolve 5 pellets under the tongue 3 times a day until symptoms are relieved or as directed by a doctor.

INACTIVE INGREDIENT SECTION

lactose, sucrose

OTC - QUESTIONS SECTION

BoironUSA.com Info@boiron.com

1-800-BOIRON-1 (1-800-264-7661),


Distributed by Boiron, Inc.

Newtown Square, PA 19073

Made in France

SPL UNCLASSIFIED SECTION

Do not use if pellet dispenser seal is broken.

Do not use if glued carton end flaps are open or if pellet dispenser seal is broken.

contains 0.25 g of sugar per dose

retain carton for full drug facts

Approx. 80 Pellets each

Total 240 Pellets

How to dispense pellets? Turn tube upside down. Twist until 5 pellets are dispensed. Remove cap and pour pellets under the tongue.

Fever Relief*

No Known Drug Interactions

*CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED.

*C,K,CK, and X are homeopathic dilutions: see BoironUSA.com/info for details.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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LabelLabel

LABELLABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0220-0035-41Aconitum napellus30 [hp_C] in 1 TUBEPELLET307
0220-0035-43Aconitum napellus3 in 1 BOXPELLET37
0220-0035-43Aconitum napellus30 [hp_C] in 1 TUBEPELLET307

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0220-00350220-0035-41, 0220-0035-43

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

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
Aconitum napellusACONITUM NAPELLUSBoiron840f7e2c-d7a3-d2ac-e053-2991aa0ac04a2025-09-10Exact identifier
ndc (package): 0220-0035-43
ndc (package): 0220-0035-41
ndc (product): 0220-0035
ndc11 (package): 00220003541
ndc11 (package): 00220003543
spl id: 3e75c5cb-c360-9be7-e063-6394a90a8a1f
spl set id: 840f7e2c-d7a3-d2ac-e053-2991aa0ac04a

Reported adverse events (FAERS/openFDA)#

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