Otc - Active Ingredient
Belladonna 3C, Sanguinaria canadensis 3C, Spigelia anthelmia 3C
Sinusalia
FDA Label NDC 0220-9341
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 Sinusalia (NDC 0220-9341). 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, indications & usage, inactive ingredient, how supplied, otc - purpose, storage and handling, otc - questions, otc - ask doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Indications & Usage
Temporary relieves nasal congestion and pain due to the common cold or allergies.
Inactive Ingredient
Croscarmellose sodium, lactose, magnesium stearate.
How Supplied
60 tablets
Otc - Purpose
Belladonna 3C HPUS relieves sinus pain with stuffy nose
(contains less than 10
-8 mg alkaloids)
Sanguinaria canadensis 3C HPUS relieves sinus pain with runny nose
Spegelia anthelmia 3C HPUS relieves sinus pain with postnasal drip
Storage And Handling
Store at 68-77 o F (20-25 o C)
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
Otc - Ask Doctor
Ask a doctor before use in children younger than 6 years of age.
If symptoms are accompanied by fever.
Otc - Stop Use
Stop use and ask a doctor if symptoms persist continuously 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
If pregnant or breast-feeding, ask a health professional before use.
Otc - When Using
Drug Interactions
Non drowsy, no drug interactions
Warnings
Do not use if blister seal is broken
Dosage & Administration
(adults and children 6 years of age and older)
Take 1 dose (2 tablets) every 2 hours up to 6 times a day.
Allow tablets to dissolve in the mouth.
Package Label.Principal Display Panel
Box (Sinusalia)
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