The following Structured Product Label (SPL) was submitted to the FDA by Boiron for the product Sinuscalm Allergy (NDC 0220-9286). 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, warnings, otc - stop use, otc - pregnancy or breast feeding, otc - keep out of reach of children, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Active ingredients** (in each tablet)
Belladonna 3C HPUS (0.83 mg) (contains less than 10 -8 mg atropine alkaloids)
Sanguinaria canadensis 3C HPUS (0.83 mg) (contains less than 10 -7 mg chelidonine alkaloids)
Spigelia anthelmia 3C HPUS (0.83 mg)
The letters “HPUS” indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.
Purpose*
Belladonna 3C HPUS (0.83 mg) ………. .…………………………Relieves sinus pain with stuffy nose caused by allergies
Sanguinaria canadensis 3C HPUS (0.83 mg)……..…………Relieves sinus pain with runny nose caused by allergies
Spigelia anthelmia 3C HPUS (0.83 mg) …………………….Relieves sinus pain with postnasal drip caused by allergies
Uses*
temporarily relieves sinus symptoms due to allergies such as:
▪ nasal congestion ▪ sinus pain ▪ headache ▪ sinus pressure
Ask a doctor before use if you have a fever.
Stop use and ask a doctor if ▪ pain or nasal congestion gets worse or lasts more than 7 days ▪ fever gets worse or lasts more than 3 days ▪ redness or swelling is present ▪ new symptoms occur
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Adults 18 years of age and older: At the onset of symptoms, dissolve 2 tablets in the mouth every 2 hours, up to 6 times per day. Decrease frequency with improvement.
croscarmellose sodium, lactose, magnesium stearate
do not use if glued carton end flaps are open or if the blister seal is broken
store below 86°F (30°C)
retain carton for full drug facts
Made in France
Distributed by Boiron Inc.
Newtown Square, PA 19073
SINUS RELIEF*
Sinus Pressure Headache Congestion & Pain*
60 MELTAWAY TABLETS Unflavored
No Known Drug Interactions
Non-Drowsy
*CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE, NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED.
**C, K, CK and X are homeopathic dilutions: see BoironUSA.com/info for details.
* Please review the disclaimer below.
