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#

ProductSINUSCALM
Active ingredientATROPA BELLADONNA, SANGUINARIA CANADENSIS ROOT, SPIGELIA ANTHELMIA
Label structure12 sections

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

LABELLABEL

LABELLABEL

LABELLABEL

LABELLABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0220-9338-04SINUSCALM60 in 1 CARTONTABLET604
0220-9338-29SINUSCALM120 in 1 CARTONTABLET1204
0220-9338-92SINUSCALM100 in 1 CARTONTABLET1004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0220-9338SINUSCALM (ATROPA BELLADONNA, SANGUINARIA CANADENSIS ROOT, SPIGELIA ANTHELMIA) TABLET [BOIRON]4Current NDC, Legacy NDC, 3 package rows20250323_87fe007d-3911-c95a-e053-2995a90ad836.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0220-93380220-9338-04, 0220-9338-29, 0220-9338-92

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Source Document#

Source XML

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SINUSCALMATROPA BELLADONNA, SANGUINARIA CANADENSIS ROOT, SPIGELIA ANTHELMIABOIRON87fe007d-3911-c95a-e053-2995a90ad8362025-03-20Exact identifier
ndc (package): 0220-9338-29
ndc (package): 0220-9338-04
ndc (package): 0220-9338-92
ndc (product): 0220-9338
ndc11 (package): 00220933829
ndc11 (package): 00220933804
ndc11 (package): 00220933892
spl id: 30d151ea-1ab5-503e-e063-6394a90a1c1a
spl set id: 87fe007d-3911-c95a-e053-2995a90ad836

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.