FDA Label for Sinuscalm Allergy
View Indications, Usage & Precautions
Sinuscalm Allergy Product Label
The following document was submitted to the FDA by the labeler of this product Boiron. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
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 (0.83mg)
The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.
Otc - Purpose
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 (0.83mg) ... Relieves sinus pain with postnasal drip caused by allergies
Indications & Usage
Uses*
temporarily relieves sinus symptoms due to allergies such as:
- nasal congestion
- sinus pain
- headache
- sinus pressure
Otc - Ask Doctor
Ask a doctor before use if you have a fever.
Otc - Stop Use
Stop use and ask a doctor if symptoms persist for more than 3 days, worsen, or if new symptoms occur. These could be signs of a serious condition.
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 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 2 tablets under the tongue every 2 hours, up to 6 times per day. Decrease frequency with improvement.
Children under 6 years of age: Ask a doctor.
Inactive Ingredient
croscarmellose sodium, lactose, magnesium stearate
Other
Sinus Relief*
Sinus Pressure Headache Congestion & Pain*
do not use if glued carton flaps are open or if the blister seal is broken
store below 86° F (30° C)
No Known Drug Interactions
Non-Drowsy
60 MELTAWAY TABLETS
Unflavored
No Phenylephrine
No Artificial Colors
No Artificial Flavors
No Artificial Sweeteners
No Rebound Congestion
Gluten-free
*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.
Otc - Questions
BoironUSA.com
1-800-BOIRON-1
(1-800-264-7661)
* Please review the disclaimer below.