SINUS
SINUS is an FDA drug label for the active ingredient PULSATILLA, EUPHORBIUM, ALLIUM CEPA, HISTAMINUM, LUFFA OPERCULATA, SABADILLA, HEPAR SULFUR. manufactured by Be Well Medical dba Richard Clement Nutrition y Be Well Homeopathics administered by NASAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20211229.
- Generic name
- PULSATILLA, EUPHORBIUM, ALLIUM CEPA, HISTAMINUM, LUFFA OPERCULATA, SABADILLA, HEPAR SULFUR.
- Product type
- HUMAN OTC DRUG
- Route
- NASAL
- Dosage form
- N/A
- NDC
- 66492-004
- Application
- N/A
- Label effective
- 20211229
About this product
SINUS is an FDA-registered drug product whose active ingredient is PULSATILLA, EUPHORBIUM, ALLIUM CEPA, HISTAMINUM, LUFFA OPERCULATA, SABADILLA, HEPAR SULFUR.. It is labelled by Be Well Medical dba Richard Clement Nutrition y Be Well Homeopathics taken by nasal and marketed as a human otc drug product. Identifiers on file: NDC 66492-004, label effective 20211229. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.
What it is used for
Across FDA labelling, products containing PULSATILLA, EUPHORBIUM, ALLIUM CEPA, HISTAMINUM, LUFFA OPERCULATA, SABADILLA, HEPAR SULFUR. are most often described in connection with: temporary relief, chronic rhinitis. Wording differs between labels, and the full indications section on this page takes precedence when it is present.
Active ingredients
Indications & Usage
INDICATIONS: For the temporary relief of acute and chronic rhinitis, sinusitis and hayfever.
Dosage & Administration
DOSAGE: 1 spray in each nostril three to eight times daily.
Warnings
WARNINGS: If symptoms persist or worsen, a health professional should be consulted. As with any drug, if you are pregnant or nursing seek the advice of your physician before using the product. KEEP THIS AND ALL MEDICINES OUT OF THE REACH OF CHILDREN. Keep out of reach of children.
Recall and safety notices
5 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.
| Recall | Product | Firm | Class | Status | Reported |
|---|---|---|---|---|---|
| D-0620-2026 | BEEKEEPER'S NATURALS Saline Nasal Spray, Sinus Congestion Rinse, Made with Propolis + Xylitol, 1 FL OZ (30 mL) per bottle, Manufactured For: Beekeeper's Naturals USA Inc., Covina, CA 91789. | BEEKEEPER'S NATURALS USA INC. | Class I | Ongoing | 20260617 |
| D-0277-2026 | TYLENOL a) 500 MG., 2'S DISPLAY, 50CT; b) COLD & FLU, 25CT/2S; c) COLD & FLU SEVERE, 2PK, 50CT; d) PM, 50CT; e) SINUS SEVERE, 2PK, 50CT | GOLD STAR DISTRIBUTION INC | Class II | Ongoing | 20260121 |
| D-0067-2024 | ION*Sinus Spray, 1 fl oz/ 30 mL, Manufactured by: ION* Biome Charlottesville, VA | Biomic Sciences, LLC dba ION Intelligence of Nature | Class I | Terminated | 20231101 |
| D-0069-2024 | Restore Sinus Spray, Manufactured by: Biomic Sciences, LLC Charlottesville, VA | Biomic Sciences, LLC dba ION Intelligence of Nature | Class II | Terminated | 20231101 |
| D-0068-2024 | ION* Sinus Support Nasal Spray, 1 fl oz/30 ml bottles, Manufactured by: ION* Intelligence of Nature Charlottesville, VA | Biomic Sciences, LLC dba ION Intelligence of Nature | Class II | Terminated | 20231101 |
Frequently asked questions
What is SINUS used for?
INDICATIONS: For the temporary relief of acute and chronic rhinitis, sinusitis and hayfever.
Who makes SINUS?
Be Well Medical dba Richard Clement Nutrition y Be Well Homeopathics is the labeler of record for SINUS.
What form does SINUS come in?
administered by nasal. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.
Is SINUS prescription or over-the-counter?
The FDA label for this product is recorded as human otc drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.
Has SINUS been recalled?
5 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.
Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.
This page reproduces FDA Structured Product Labelling data for identification and reference. It is not medical advice, does not diagnose or treat any condition, and does not sell or price any medicine.