Otc - Active Ingredient
Aconitum napellus 6C, Belladona 6C, Calendula officinalis 6C, Chelidonium majus 6C, Jequirity 6C, Viburnum opulus 6C
Sedalia
FDA Label NDC 0220-9332
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Laboratoires Boiron for the product Sedalia (NDC 0220-9332). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, otc - stop use, otc - ask doctor, otc - when using, otc - keep out of reach of children, description, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Aconitum napellus 6C Relieves restlessness, agitation
Belladona 6C Relieves hypersensitivity to stress
Calendula officinalis 6C Relieves nervous fatigue, hypersensitivity to noise
Chelidonium majus 6C Relieves digestive symptoms caused by stress
Jequirity 6C Relieves uneasiness
Viburnum opulus 6C Relieves nervousness and restless sleep
Indications & Usage
For temporary relief of nervousness, hypersensitivity and irritability due to stress.
Otc - Stop Use
Stop use and ask a doctor if symptoms persist continuously for more than 2 weeks or worsen.
Otc - Ask Doctor
Ask a doctor before use in children younger than 12 years of age.
Otc - When Using
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children
Description
Directions: (adults and children 12 years of age and older):
Allow 3 tablets to dissolve in the mouth 3 times a day.
Storage And Handling
Store at 68-77 o F (20-25 o C)
Drug Interactions
Non habit forming, no drug interactions
Inactive Ingredient
Croscarmellose sodium, lactose, magnesium stearate.
Otc - Questions
Questions, Comments
www.boironusa.com
[email protected]
1-800-BOIRON-1
(1-800-264-7661)
Boiron Information Center
6 campus Bouelvard
Newtown Square, PA
19073-3267
How Supplied
60 tablets
Warnings
Dosage & Administration
Adult and children 12 years of age and older: dissolve 2 tablets in the mouth 3 times a day.
Package Label.Principal Display Panel
Box (Sedalia)
* Please review the disclaimer below.
