SINUSCALM
- Manufacturer
- BOIRON | BOIRON, INC.
- Effective date
- 2025-03-20
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 4
- Source
- full-release
- Hydrated at
- 2026-06-01 02:32:42
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
Sanguinaria canadensis 3C HPUS (0.83 mg)…Relieves sinus pain with runny nose
Spigelia anthelmia 3C HPUS (0.83 mg)…Relieves sinus pain with postnasal drip
INDICATIONS & USAGE SECTION
Uses*
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 - STOP USE 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 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 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 2 tablets under the tongue every 2 hours, up to 6 times a day. 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 the blister seal is broken.
Store below 86° F (30° C)
60 Meltaway Tablets unflavored
100 Meltaway Tablets unflavored
120 Meltaway Tablets unflavored
Sinus Relief*
Sinus Pressure, Headache, Congestion & Pain*
Year-Round Sinus Relief for Colds & Allergies*
Non-Drowsy
*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
croscarmellose sodium, lactose, magnesium stearate
OTC - QUESTIONS SECTION
Questions or comments?
BoironUSA.com
Info@Boiron.com
1-800-BOIRON-1 (1-800-264-7661)
Made in France
Distributed by Boiron Inc.
Newtown Square, PA 19073
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0220-9338-04 | SINUSCALM | 60 in 1 CARTON | TABLET | 60 | 4 | |
| 0220-9338-29 | SINUSCALM | 120 in 1 CARTON | TABLET | 120 | 4 | |
| 0220-9338-92 | SINUSCALM | 100 in 1 CARTON | TABLET | 100 | 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
- CROSCARMELLOSE SODIUM
- CROSCARMELLOSE
- ATROPA BELLADONNA
- SANGUINARIA CANADENSIS ROOT
- MAGNESIUM STEARATE
- SPIGELIA ANTHELMIA
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 0220-9338 | 0220-9338-04, 0220-9338-29, 0220-9338-92 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| LACTOSE, UNSPECIFIED FORM | J2B2A4N98G | IACT |
| CROSCARMELLOSE SODIUM | M28OL1HH48 | IACT |
| ATROPA BELLADONNA | WQZ3G9PF0H | ACTIB |
| SANGUINARIA CANADENSIS ROOT | N9288CD508 | ACTIB |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| 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 | 87fe007d-3911-c95a-e053-2995a90ad836 | 2025-03-20 | 0220-9338-29 0220-9338-04 0220-9338-92 0220-9338 00220933829 00220933804 00220933892 30d151ea-1ab5-503e-e063-6394a90a1c1a 87fe007d-3911-c95a-e053-2995a90ad836 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.



