FDA Label for Sedalia
View Indications, Usage & Precautions
- OTC - ACTIVE INGREDIENT
- OTC - PURPOSE
- INDICATIONS & USAGE
- OTC - STOP USE
- OTC - ASK DOCTOR
- OTC - WHEN USING
- OTC - KEEP OUT OF REACH OF CHILDREN
- DESCRIPTION
- STORAGE AND HANDLING
- DRUG INTERACTIONS
- INACTIVE INGREDIENT
- OTC - QUESTIONS
- HOW SUPPLIED
- WARNINGS
- DOSAGE & ADMINISTRATION
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Sedalia Product Label
The following document was submitted to the FDA by the labeler of this product Laboratoires Boiron. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
Aconitum napellus 6C, Belladona 6C, Calendula officinalis 6C, Chelidonium majus 6C, Jequirity 6C, Viburnum opulus 6C
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
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