Sinusalia
FDA Label NDC 0220-9346

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 0220-9346). 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, otc - do not use, dosage & administration, inactive ingredient, how supplied, otc - purpose, storage and handling, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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.

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.

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


* Please review the disclaimer below.