FDA Label for Sinusalia
View Indications, Usage & Precautions
- OTC - ACTIVE INGREDIENT
- INDICATIONS & USAGE
- OTC - DO NOT USE
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
- HOW SUPPLIED
- OTC - PURPOSE
- STORAGE AND HANDLING
- OTC - QUESTIONS
- OTC - ASK DOCTOR
- OTC - STOP USE
- OTC - KEEP OUT OF REACH OF CHILDREN
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - WHEN USING
- WARNINGS
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Sinusalia 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
Belladonna 3C, Sanguinaria canadensis 3C, Spigelia anthelmia 3C
Indications & Usage
Temporary relieves nasal congestion, sinus pain and headache, due to common cold or allergies.
Otc - Do Not Use
Do not use if pellet dispenser seal is broken
Dosage & Administration
Adults and children 6 years of age and older: Dissolve 5 pellets in the mouth every 2 hours up to 6 times a day until symptoms are relieved.
Inactive Ingredient
lactose, sucrose.
How Supplied
Approx. 80 pellets, 3.8 g (0.133 oz.).
Otc - Purpose
Belladonna 3C..... Relieves sinus pain with stuffy nose
Sanguinaria canadensis 3C ..... Relieves sinus pain with runny nose
Spigelia anthelmia 3C ..... Relieves sinus pain with postnasal drip.
Storage And Handling
Otc - Questions
Questions, Comments?
www.boironusa.com
1-800-BOIRON-1
(1-800-264-7661)
Distributed by Boiron Inc.
6 campus boulevard
Newtown Square, PA 19073-3267
Otc - Ask Doctor
Ask a doctor before use in children younger than 6 years of age or if symptoms are accompanied by fever.
Otc - Stop Use
Stop use and ask doctor if symptoms persist for more than 3 days or worsen.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Otc - Pregnancy Or Breast Feeding
Otc - When Using
Warnings
Package Label.Principal Display Panel
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