SINUSCALM- atropa belladonna, sanguinaria canadensis root, spigelia anthelmia whole tablet

SinusCalm by

Drug Labeling and Warnings

SinusCalm by is a Homeopathic medication manufactured, distributed, or labeled by Boiron, Boiron, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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.

PURPOSE

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

Uses*

temporarily relieves sinus symptoms due to colds or allergies such as:

• nasal congestion
• sinus pain
• headache

WARNINGS

Ask a doctor before use if you have a fever.

STOP USE

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

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

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

croscarmellose sodium, lactose, magnesium stearate

QUESTIONS

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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SINUSCALM 
atropa belladonna, sanguinaria canadensis root, spigelia anthelmia whole tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0220-9285
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SPIGELIA ANTHELMIA (UNII: WYT05213GE) (SPIGELIA ANTHELMIA - UNII:WYT05213GE)	SPIGELIA ANTHELMIA	3 [hp_C]
ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H)	ATROPA BELLADONNA	3 [hp_C]
SANGUINARIA CANADENSIS ROOT (UNII: N9288CD508) (SANGUINARIA CANADENSIS ROOT - UNII:N9288CD508)	SANGUINARIA CANADENSIS ROOT	3 [hp_C]

Inactive Ingredients
Ingredient Name	Strength
LACTOSE (UNII: J2B2A4N98G)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
MAGNESIUM STEARATE (UNII: 70097M6I30)

Product Characteristics
Color	white	Score	no score
Shape	ROUND (Boiron)	Size	9mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0220-9285-04	3 in 1 CARTON	02/15/2026
1		20 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		02/15/2026

Labeler - Boiron (282560473)

Registrant - Boiron, Inc. (014892269)

Establishment
Name	Address	ID/FEI	Business Operations
Boiron		282560473	manufacture(0220-9285)