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#

ProductSinusCalm
Active ingredientSPIGELIA ANTHELMIA, ATROPA BELLADONNA, SANGUINARIA CANADENSIS ROOT
Label structure13 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 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

LABELLABELLABELLABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0220-9285-04SinusCalm20 in 1 BLISTER PACKTABLET201
0220-9285-04SinusCalm3 in 1 CARTONTABLET31

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0220-92850220-9285-04

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 ANTHELMIA WHOLEBoiron4ae58d81-3952-b372-e063-6394a90a84992026-02-15WarningsExact identifier
ndc (package): 0220-9285-04
ndc (product): 0220-9285
ndc11 (package): 00220928504
spl id: 4ae58d81-3953-b372-e063-6394a90a8499
spl set id: 4ae58d81-3952-b372-e063-6394a90a8499

Reported adverse events (FAERS/openFDA)#

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