Otc - Active Ingredient
BELLADONNA 3C HPUS (0.8MG), SANGUINARIA CANADENSIS 3C HPUS (0.8 MG) ,SPIGELIA ANTHELMIA 3C HPUS (0.8 MG)**
Sinuscalm Tablet
FDA Label NDC 0220-9338
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 0220-9338). 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 - 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.
Label Section Quick Index
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*
(contains less than 10 -8 mg alkaloids)
SPIGELIA ANTHELMIA 3C HPUS RELIEVES SINUS PAIN WITH POST NASAL DRIP*
(contains less than 10 -8 mg alkaloids)
Indications & Usage
TEMPORARILY RELIEVES NASAL CONGESTION SINUS PAIN HEADACHE DUE TO THE COMMON COLD OR ALLERGIES
Otc - Ask Doctor
Ask a doctor before use in children under 6 years of age.
Otc - Stop Use
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 breast-feeding 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, allow 2 tablets to dissolve 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 glued carton end flaps are open or if the blister seal is broken.
Contains 60 Tablets
Store below 86° F (30° C)
*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, CROSCARMELLOSE SODIUM, MAGNESIUM STEARATE
Otc - Questions
1-800-BOIRON-1 (1-800-264-7661),
BoironUSA.com [email protected]
Distributed by Boiron, Inc. Newtown Square, PA 19073
* Please review the disclaimer below.
