Sinuscalm Allergy

Sinuscalm Allergy
SPL v2
SPL
SPL Set ID e4e0b0b3-df5e-6d47-e053-2a95a90aeba8
Route
ORAL
Published
Effective Date 2022-07-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Atropa Belladonna (3 [hp_C]) Spigelia Anthelmia Sanguinaria Canadensis Root
Inactive Ingredients
Croscarmellose Sodium Magnesium Stearate Lactose, Unspecified Form

Identifiers & Packaging

Pill Appearance
Imprint: Boiron Shape: round Color: white Size: 9 mm Score: 1
Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2022-07-28

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 (0.83mg) The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.


Medication Information

Indications and Usage

Uses*

temporarily relieves sinus symptoms due to allergies such as:

  • nasal congestion
  • sinus pain
  • headache
  • sinus pressure
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 per 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 (0.83mg) The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.

Section 42229-5

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.

Section 50565-1

Keep out of reach of children. In case of 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

BoironUSA.com

[email protected]

1-800-BOIRON-1

(1-800-264-7661)

Section 53414-9

If pregnant or breastfeeding, ask a health professional before use.

Section 55105-1

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

Section 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 (0.83mg)

The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.


Structured Label Content

Indications and Usage (34067-9)

Uses*

temporarily relieves sinus symptoms due to allergies such as:

  • nasal congestion
  • sinus pain
  • headache
  • sinus pressure
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 per day. Decrease frequency with improvement.

Children under 6 years of age: Ask a doctor.

Section 42229-5 (42229-5)

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.

Section 50565-1 (50565-1)

Keep out of reach of children. In case of 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)

BoironUSA.com

[email protected]

1-800-BOIRON-1

(1-800-264-7661)

Section 53414-9 (53414-9)

If pregnant or breastfeeding, ask a health professional before use.

Section 55105-1 (55105-1)

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

Section 55106-9 (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 (0.83mg)

The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.


Advanced Ingredient Data


Raw Label Data

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