sinuscalm

sinuscalm
SPL v4
SPL
SPL Set ID 87fe007d-3911-c95a-e053-2995a90ad836
Route
oral
Published
Effective Date 2025-03-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
atropa belladonna (3 [hp_C]) sanguinaria canadensis root spigelia anthelmia
Inactive Ingredients
anhydrous lactose croscarmellose magnesium stearate

Identifiers & Packaging

Pill Appearance
Imprint: Boiron Shape: round Color: white Size: 9 mm Score: 1
Marketing Status
unapproved homeopathic active Since 2019-06-01

Description

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.


Medication Information

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.

Indications and Usage

Uses*

temporarily relieves sinus symptoms due to the common cold or allergies such as: ▪ nasal congestion ▪ sinus pain ▪ headache

Dosage and Administration

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.

Description

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.

Section 42229-5

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.

Section 50565-1

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

Section 50566-9

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.

Section 50569-3

Ask a doctor before use if you have a fever.

Section 51727-6

croscarmellose sodium, lactose, magnesium stearate

Section 51945-4

Section 53413-1

Questions or comments?

BoironUSA.com

[email protected]

1-800-BOIRON-1 (1-800-264-7661)

Made in France

Distributed by Boiron Inc.

Newtown Square, PA 19073

Section 53414-9

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

Section 55105-1

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


Structured Label Content

Active Ingredient (55106-9)

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.

Indications and Usage (34067-9)

Uses*

temporarily relieves sinus symptoms due to the common cold or allergies such as: ▪ nasal congestion ▪ sinus pain ▪ headache

Dosage and Administration (34068-7)

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.

Section 42229-5 (42229-5)

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.

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

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.

Section 50569-3 (50569-3)

Ask a doctor before use if you have a fever.

Section 51727-6 (51727-6)

croscarmellose sodium, lactose, magnesium stearate

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions or comments?

BoironUSA.com

[email protected]

1-800-BOIRON-1 (1-800-264-7661)

Made in France

Distributed by Boiron Inc.

Newtown Square, PA 19073

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

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


Advanced Ingredient Data


Raw Label Data

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