Sinusalia

Sinusalia
SPL v8
SPL
SPL Set ID 70fb54b2-cd9b-4b22-83de-b5455186c846
Route
ORAL
Published
Effective Date 2011-03-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Belladonna Leaf (3 [hp_C]) Sanguinaria Canadensis Root Spigelia Marilandica Root
Inactive Ingredients
Croscarmellose Sodium Lactose Magnesium Stearate

Identifiers & Packaging

Pill Appearance
Imprint: ; Shape: round Color: white Size: 9 mm Score: 1
Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2011-04-01

Description

Belladonna 3C, Sanguinaria canadensis 3C, Spigelia anthelmia 3C


Medication Information

Warnings and Precautions

Do not use if blister seal is broken

Indications and Usage

Temporary relieves nasal congestion and pain due to the common cold or allergies.

Dosage and Administration

(adults and children 6 years of age and older)

Take 1 dose (2 tablets) every 2 hours up to 6 times a day.

Allow tablets to dissolve in the mouth.

Dosage Forms and Strengths

60 tablets

Description

Belladonna 3C, Sanguinaria canadensis 3C, Spigelia anthelmia 3C

Section 34073-7

Non drowsy, no drug interactions

Section 44425-7

Store at 68-77 F (20-25 o C)

Section 50565-1

Keep out of reach of children

Section 50566-9

Stop use and ask a doctor if symptoms persist continuously for more than 3 days or worsen.

Section 50567-7



Section 50569-3

Ask a doctor before use in children younger than 6 years of age.



If symptoms are accompanied by fever.





Section 51727-6

Croscarmellose sodium, lactose, magnesium stearate.

Section 51945-4

Section 53413-1

Questions, Comments

www.boironusa.com

[email protected]

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

Boiron Information Center

6 campus Bouelvard

Newtown Square, PA

19073-3267

Section 53414-9

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

Section 55105-1

Belladonna 3C HPUS relieves sinus pain with stuffy nose

(contains less than 10 -8 mg alkaloids)



Sanguinaria canadensis 3C HPUS relieves sinus pain with runny nose



Spegelia anthelmia 3C HPUS relieves sinus pain with postnasal drip





Section 55106-9

Belladonna 3C, Sanguinaria canadensis 3C, Spigelia anthelmia 3C


Structured Label Content

Indications and Usage (34067-9)

Temporary relieves nasal congestion and pain due to the common cold or allergies.

Dosage and Administration (34068-7)

(adults and children 6 years of age and older)

Take 1 dose (2 tablets) every 2 hours up to 6 times a day.

Allow tablets to dissolve in the mouth.

Dosage Forms and Strengths (34069-5)

60 tablets

Warnings and Precautions (34071-1)

Do not use if blister seal is broken

Section 34073-7 (34073-7)

Non drowsy, no drug interactions

Section 44425-7 (44425-7)

Store at 68-77 F (20-25 o C)

Section 50565-1 (50565-1)

Keep out of reach of children

Section 50566-9 (50566-9)

Stop use and ask a doctor if symptoms persist continuously for more than 3 days or worsen.

Section 50567-7 (50567-7)



Section 50569-3 (50569-3)

Ask a doctor before use in children younger than 6 years of age.



If symptoms are accompanied by fever.





Section 51727-6 (51727-6)

Croscarmellose sodium, lactose, magnesium stearate.

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions, Comments

www.boironusa.com

[email protected]

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

Boiron Information Center

6 campus Bouelvard

Newtown Square, PA

19073-3267

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Belladonna 3C HPUS relieves sinus pain with stuffy nose

(contains less than 10 -8 mg alkaloids)



Sanguinaria canadensis 3C HPUS relieves sinus pain with runny nose



Spegelia anthelmia 3C HPUS relieves sinus pain with postnasal drip





Section 55106-9 (55106-9)

Belladonna 3C, Sanguinaria canadensis 3C, Spigelia anthelmia 3C


Advanced Ingredient Data


Raw Label Data

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