SinusCalm
- Manufacturer
- Boiron | Boiron, Inc.
- Effective date
- 2023-10-30
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 4
- Source
- full-release
- Hydrated at
- 2026-06-01 02:22:57
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
Belladonna 3C HPUS (0.14 mg), Sanguinaria canadensis 3C HPUS (0.14 mg), Spigelia anthelmia 3C HPUS(0.14 mg) **
(in each pellet)
OTC - PURPOSE SECTION
Belladonna 3C HPUS Relieves sinus pain and stuffy nose*
(contains less than 10 -9 mg atropine alkaloids per pellet)
Sanguinaria canadensis 3C HPUS Relieves sinus pain with runny hose*
(contains less than 10- 8 mg chelidonine alkaloids per pellet)
Spigelia anthelmia 3C HPUS Relieves sinus pain with postnasal drip*
The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.
INDICATIONS & USAGE SECTION
Temporarily relieves sinus symptoms due to the common cold or allergies such as: nasal congestion, sinus pain, headache
OTC - ASK DOCTOR SECTION
Ask a doctor before use if you have a fever
OTC - ASK DOCTOR SECTION
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 SECTION
If pregnant or breastfeeding, ask a health professional before use.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away.
DOSAGE & ADMINISTRATION SECTION
Adults and children 6 years of age and older: At the onset of symptoms, dissolve 5 pellets under the tongue every 2 hours up to 6 times a day until symptoms are relieved. Decrease frequency with improvement. Children under 6 years of age: Ask a doctor.
SPL UNCLASSIFIED SECTION
do not use if glued carton end flaps are open or if pellet dispenser seal is broken.
Contains approx 80 quick dissolving pellets per tube.
How to dispense pellets? Turn tube upside down. Twist until 5 pellets are dispensed into cap. Carefully remove the cap and use it to pour pellets under the tongue.
Tubes contains approx. 80 pellets, 3.8 g (0.13 oz)
2 Tubes
16 Doses per tube
Year-round sinus relief for colds & allergies
Plant-based actives
Non-drowsy
Formally Sinusalia
Do not use if glued carton and flaps are open or if pellet dispenser seal is broken.
*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 SECTION
lactose, sucrose
OTC - QUESTIONS SECTION
1-800-BOIRON-1 (1-800-264-7661),
BoironUSA.com Info@boiron.com
Distributed by Boiron, Inc. Newtown Square, PA 19073
Made in France
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 0220-9347-42 | 2023-10-31 | C162847 | 48780-1 | f386c64a-31ff-0266-e053-dadaa90a7c1a | SinusCalm |
| 0220-9347-42 | 2023-01-30 | C162847 | 48780-1 | f386c64a-31ff-0266-e053-dadaa90a7c1a | SinusCalm |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0220-9347-41 | SinusCalm | 80 in 1 TUBE | PELLET | 80 | 4 | |
| 0220-9347-42 | SinusCalm | 1 in 1 BOX | PELLET | 1 | 4 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- SinusCalm
- ATROPA BELLADONNA, SANGUINARIA CANADENSIS ROOT, SPIGELIA ANTHELMIA
- LACTOSE, UNSPECIFIED FORM
- ANHYDROUS LACTOSE
- SANGUINARIA CANADENSIS ROOT
- SUCROSE
- ATROPA BELLADONNA
- SPIGELIA ANTHELMIA
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 0220-9347 | 0220-9347-41, 0220-9347-42 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| LACTOSE, UNSPECIFIED FORM | J2B2A4N98G | IACT |
| SANGUINARIA CANADENSIS ROOT | N9288CD508 | ACTIB |
| SUCROSE | C151H8M554 | IACT |
| ATROPA BELLADONNA | WQZ3G9PF0H | ACTIB |
| SPIGELIA ANTHELMIA | WYT05213GE | 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 | Boiron | 95872748-6d70-5c80-e053-2995a90a570c | 2023-10-30 | 0220-9347-42 0220-9347-41 0220-9347 00220934742 00220934741 08f2e848-c96f-4947-e063-6394a90a7310 95872748-6d70-5c80-e053-2995a90a570c |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.


