Otc - Active Ingredient
Sinapis nigra 30C
Sinapis Nigra Pellet
FDA Label NDC 0220-4678
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 Sinapis Nigra (NDC 0220-4678). 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 - stop use, otc - pregnancy or breast feeding, otc - keep out of reach of children, dosage & administration, other, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Indications & Usage
Cold or hay fever with post nasal drip at night*
Otc - Stop Use
Stop use and ask a doctor if symptoms persist for more than 3 days or worsen
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
Dosage & Administration
5 pellets 3 times a day until symptoms are relieved
Other
Do not use if pellet dispenser seal is broken, contains approx 80 pellets
These "Uses" have not been evaluated by the FDA
Inactive Ingredient
lactose, sucrose
Otc - Questions
1-800-BOIRON-1, Newtown Square, PA 19073-3267, [email protected]
* Please review the disclaimer below.
