Otc - Active Ingredient
Belladonna 3C HPUS (0.14 mg), Sanguinaria canadensis 3C HPUS (0.14 mg), Spigelia anthelmia 3C HPUS(0.14 mg) **
(in each pellet)
Sinuscalm Pellet
FDA Label NDC 0220-9347
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Boiron for the product Sinuscalm (NDC 0220-9347). 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, otc - ask doctor, otc - pregnancy or breast feeding, otc - keep out of reach of children, dosage & administration, other, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Belladonna 3C HPUS Relieves sinus pain and stuffy nose
(contains less than 10-10 mg alkaloids per pellet)
Sanguinaria canadensis 3C HPUS Relieves sinus pain with runny hose
(contains less than 10-9 mg alkaloids per pellet)
Spigelia anthelmia 3C HPUS Relieves sinus pain with postnasal drip
The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.
Indications & Usage
Temporarily relieves sinus symptoms due to the common cold or allergies such as: nasal congestion, sinus pain, headache
Otc - Ask Doctor
Stop use and ask a doctor if symptoms persist for more than 3 days, worsen, or are accompanied by a fever.
Otc - Pregnancy Or Breast Feeding
If pregnant or breastfeeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away.
Dosage & Administration
Adults and children 6 years of age and older: At the onset of symptoms, dissolve 5 pellets under the tongue every 2 hours up to 6 times a day until symptoms are relieved. Children under 6 years of age: Ask a doctor.
Other
Do not use if pellet dispenser seal is broken.
Contains approx 80 quick dissolving pellets per tube.
How to dispense pellets? Turn tube upside down. Twist until 5 pellets are dispensed into cap. Carefully remove the cap and use it to pour pellets under the tongue.
Formally Sinusalia
*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.
Inactive Ingredient
lactose, sucrose
Otc - Questions
1-800-BOIRON-1 (1-800-264-7661),
BoironUSA.com [email protected]
Distributed by Boiron, Inc. Newtown Square, PA 19073
Made in France
* Please review the disclaimer below.
