SinusCalm Tablets
- Manufacturer
- Boiron | Boiron, Inc.
- Effective date
- 2026-02-15
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-06-01 02:37:58
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
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 (0.83 mg)
The letters “HPUS” indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.
OTC - PURPOSE SECTION
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 (0.83 mg) ……………………Relieves sinus pain with postnasal drip
INDICATIONS & USAGE SECTION
Uses*
temporarily relieves sinus symptoms due to colds or allergies such as:
- nasal congestion
- sinus pain
- headache
WARNINGS SECTION
Ask a doctor before use if you have a fever.
OTC - STOP USE SECTION
Stop use and ask a doctor if
- pain or nasal congestion gets worse or lasts more than 7 days
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- new symptoms occur
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast-feeding, ask a health professional before use.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
DOSAGE & ADMINISTRATION SECTION
Adults 18 years of age older: At the onset of symptoms, dissolve 2 tablets in the mouth every 2 hours, up to 6 times per day. Decrease frequency with improvement.
SPL UNCLASSIFIED SECTION
- do not use if glued carton end flaps are open or if the blister seal is broken
- store below 86°F (30°C)
- retain carton for full drug facts
INACTIVE INGREDIENT SECTION
croscarmellose sodium, lactose, magnesium stearate
OTC - QUESTIONS SECTION
BoironUSA.com
Info@Boiron.com
1-800-BOIRON-1 (1-800-264-7661)
Made in France
Distributed by Boiron Inc.
Newtown Square, PA 19073
SPL UNCLASSIFIED SECTION
SINUS RELIEF*
Sinus Pressure Headache
Congestion & Pain*
- Year-Round Sinus Relief for Colds & Allergies*
- Non-Drowsy
60 Meltawat Tablets
*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.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0220-9285-04 | SinusCalm | 20 in 1 BLISTER PACK | TABLET | 20 | 1 | |
| 0220-9285-04 | SinusCalm | 3 in 1 CARTON | TABLET | 3 | 1 |
Products#
Every source-derived product name is available through these pages.
- SinusCalm
- ATROPA BELLADONNA, SANGUINARIA CANADENSIS ROOT, SPIGELIA ANTHELMIA WHOLE
- SPIGELIA ANTHELMIA
- LACTOSE
- CROSCARMELLOSE SODIUM
- MAGNESIUM STEARATE
- ATROPA BELLADONNA
- SANGUINARIA CANADENSIS ROOT
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 0220-9285 | 0220-9285-04 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| SPIGELIA ANTHELMIA | WYT05213GE | ACTIB |
| LACTOSE | J2B2A4N98G | IACT |
| CROSCARMELLOSE SODIUM | M28OL1HH48 | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| ATROPA BELLADONNA | WQZ3G9PF0H | ACTIB |
| SANGUINARIA CANADENSIS ROOT | N9288CD508 | ACTIB |
Source Document#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| SinusCalm | ATROPA BELLADONNA, SANGUINARIA CANADENSIS ROOT, SPIGELIA ANTHELMIA WHOLE | Boiron | 4ae58d81-3952-b372-e063-6394a90a8499 | 2026-02-15 | Warnings | 0220-9285-04 0220-9285 00220928504 4ae58d81-3953-b372-e063-6394a90a8499 4ae58d81-3952-b372-e063-6394a90a8499 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.

