FDA.reportPublic FDA data

SINUSCALM ALLERGY

Manufacturer
Boiron | Boiron, Inc.
Effective date
2023-01-18
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:19:42

Label at a glance#

ProductSINUSCALM ALLERGY
Active ingredientATROPA BELLADONNA, SPIGELIA ANTHELMIA, SANGUINARIA CANADENSIS ROOT
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 (0.83mg)

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 (0.83mg) ... Relieves sinus pain with postnasal drip caused by allergies

INDICATIONS & USAGE SECTION

Uses*

temporarily relieves sinus symptoms due to allergies such as:

  • nasal congestion
  • sinus pain
  • headache
  • sinus pressure

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 breastfeeding, 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 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 per day. Decrease frequency with improvement.

Children under 6 years of age: Ask a doctor.

INACTIVE INGREDIENT SECTION

croscarmellose sodium, lactose, magnesium stearate

SPL UNCLASSIFIED SECTION

Sinus Relief*

Sinus Pressure Headache Congestion & Pain*

do not use if glued carton flaps are open or if the blister seal is broken

store below 86° F (30° C)

No Known Drug Interactions

Non-Drowsy

60 MELTAWAY TABLETS

Unflavored

No Phenylephrine

No Artificial Colors

No Artificial Flavors

No Artificial Sweeteners

No Rebound Congestion

Gluten-free

*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.

OTC - QUESTIONS SECTION

BoironUSA.com

Info@Boiron.com

1-800-BOIRON-1

(1-800-264-7661)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0220-9339-04SINUSCALM ALLERGY1 in 1 BOXTABLET12
0220-9339-04SINUSCALM ALLERGY60 in 1 BLISTER PACKTABLET602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0220-9339SINUSCALM ALLERGY (ATROPA BELLADONNA, SANGUINARIA CANADENSIS ROOT,) TABLET [BOIRON]2Current NDC, Legacy NDC, 2 package rows20230120_e4e0b0b3-df5e-6d47-e053-2a95a90aeba8.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
0220-93390220-9339-04

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
ATROPA BELLADONNAWQZ3G9PF0HACTIB
CROSCARMELLOSE SODIUMM28OL1HH48IACT
MAGNESIUM STEARATE70097M6I30IACT
SPIGELIA ANTHELMIAWYT05213GEACTIB
LACTOSE, UNSPECIFIED FORMJ2B2A4N98GIACT
SANGUINARIA CANADENSIS ROOTN9288CD508ACTIB

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
SINUSCALM ALLERGYATROPA BELLADONNA, SANGUINARIA CANADENSIS ROOT,Boirone4e0b0b3-df5e-6d47-e053-2a95a90aeba82023-01-18Exact identifier
ndc (package): 0220-9339-04
ndc (product): 0220-9339
ndc11 (package): 00220933904
spl id: f29251a1-7d15-a1bf-e053-2a95a90a10c1
spl set id: e4e0b0b3-df5e-6d47-e053-2a95a90aeba8

Reported adverse events (FAERS/openFDA)#

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