Label: ACONITUM NAPELLUS- aconitum napellus pellet
- NDC Code(s): 0220-0035-41, 0220-0035-43
- Packager: Boiron
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved homeopathic
DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.
Drug Label Information
Updated June 5, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
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ACTIVE INGREDIENT
Tube - Aconitum napellus 30C (**contains 0.443 mg of the active ingredient per pellet)
(Less than 10 -12 mg aconitine alkaloids per pellet)
Box - Aconitum napellus 30C HPUS (**contains 0.443 mg of the active ingredient in each pellet)
(contains less than 10 -14 mg aconitine alkaloids)The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- STOP USE
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
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SPL UNCLASSIFIED SECTION
Tube - Do not use if pellet dispenser seal is broken.
Contains approx 80 pellets.
How to dispense pellets? Turn tube upside down. Twist until 5 pellets are dispensed into cap. Carefully remove the cap and use it to pour pellets under the tongue.
*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.Box - Do not use if glued carton end flaps are open or if pellet dispenser seal is broken.
3 Tubes approx 80 pellets 16 Doses per tube 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.
No known drug interactions
Adults & Children
Meltaway pellets
*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. - INACTIVE INGREDIENT
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DOSAGE & ADMINISTRATION
Tube - 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.
Box - 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.
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ACONITUM NAPELLUS
aconitum napellus pelletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0220-0035 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS 30 [hp_C] in 30 [hp_C] Inactive Ingredients Ingredient Name Strength SUCROSE (UNII: C151H8M554) LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G) Product Characteristics Color white Score Shape ROUND Size 4mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0220-0035-41 30 [hp_C] in 1 TUBE; Type 0: Not a Combination Product 03/03/1983 2 NDC:0220-0035-43 3 in 1 BOX 09/01/2020 2 30 [hp_C] in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 03/03/1983 Labeler - Boiron (282560473) Registrant - Boiron, Inc. (014892269) Establishment Name Address ID/FEI Business Operations Boiron 282560473 manufacture(0220-0035)
