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#

ProductSinusCalm
Active ingredientSANGUINARIA CANADENSIS ROOT, ATROPA BELLADONNA, SPIGELIA ANTHELMIA
Label structure12 sections

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

LABELLABELlabelslabelsBoxBoxTubeTube

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0220-9347-422023-10-31C16284748780-1f386c64a-31ff-0266-e053-dadaa90a7c1aSinusCalm
0220-9347-422023-01-30C16284748780-1f386c64a-31ff-0266-e053-dadaa90a7c1aSinusCalm

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0220-9347-41SinusCalm80 in 1 TUBEPELLET804
0220-9347-42SinusCalm1 in 1 BOXPELLET14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0220-9347SINUSCALM (ATROPA BELLADONNA, SANGUINARIA CANADENSIS ROOT, SPIGELIA ANTHELMIA) PELLET [BOIRON]4Current NDC, Legacy NDC, 2 package rows20231031_95872748-6d70-5c80-e053-2995a90a570c.zip

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
0220-93470220-9347-41, 0220-9347-42

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 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 ANTHELMIABoiron95872748-6d70-5c80-e053-2995a90a570c2023-10-30Exact identifier
ndc (package): 0220-9347-42
ndc (package): 0220-9347-41
ndc (product): 0220-9347
ndc11 (package): 00220934742
ndc11 (package): 00220934741
spl id: 08f2e848-c96f-4947-e063-6394a90a7310
spl set id: 95872748-6d70-5c80-e053-2995a90a570c

Reported adverse events (FAERS/openFDA)#

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