Sinuscalm

Sinuscalm
SPL v4
SPL
SPL Set ID 95872748-6d70-5c80-e053-2995a90a570c
Route
ORAL
Published
Effective Date 2020-12-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Sanguinaria Canadensis Root (3 [hp_C]) Atropa Belladonna Spigelia Anthelmia
Inactive Ingredients
Anhydrous Lactose Sucrose

Identifiers & Packaging

Pill Appearance
Shape: round Color: white Size: 4 mm
Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2019-12-01

Description

Belladonna 3C HPUS (0.14 mg), Sanguinaria canadensis 3C HPUS (0.14 mg), Spigelia anthelmia 3C HPUS(0.14 mg) ** (in each pellet)


Medication Information

Indications and Usage

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 5 pellets under the tongue every 2 hours up to 6 times a day until symptoms are relieved. Decrease frequency with improvement. Children under 6 years of age: Ask a doctor.

Description

Belladonna 3C HPUS (0.14 mg), Sanguinaria canadensis 3C HPUS (0.14 mg), Spigelia anthelmia 3C HPUS(0.14 mg) ** (in each pellet)

Section 42229-5

do not use if glued carton end flaps are open or if pellet dispenser seal is broken.



Contains approx 80 quick dissolving pellets per tube.

How to dispense pellets? Turn tube upside down. Twist until 5 pellets are dispensed into cap. Carefully remove the cap and use it to pour pellets under the tongue.

Tubes contains approx. 80 pellets, 3.8 g (0.13 oz)

2 Tubes

16 Doses per tube

Year-round sinus relief for colds & allergies

Plant-based actives

Non-drowsy

Formally Sinusalia

Do not use if glued carton and flaps are open or if pellet dispenser seal is broken.

*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 50569-3

Ask a doctor before use if you have a fever

Section 51727-6

lactose, sucrose

Section 51945-4

Section 53413-1

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

BoironUSA.com [email protected]

Distributed by Boiron, Inc. Newtown Square, PA 19073

Made in France

Section 53414-9

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

Section 55105-1

Belladonna 3C HPUS Relieves sinus pain and stuffy nose*

(contains less than 10 -9 mg atropine alkaloids per pellet)

Sanguinaria canadensis 3C HPUS Relieves sinus pain with runny hose*

(contains less than 10- 8 mg chelidonine alkaloids per pellet)

Spigelia anthelmia 3C HPUS Relieves sinus pain with postnasal drip*

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

Section 55106-9

Belladonna 3C HPUS (0.14 mg), Sanguinaria canadensis 3C HPUS (0.14 mg), Spigelia anthelmia 3C HPUS(0.14 mg) **

(in each pellet)


Structured Label Content

Indications and Usage (34067-9)

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 5 pellets under the tongue every 2 hours up to 6 times a day until symptoms are relieved. 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 pellet dispenser seal is broken.



Contains approx 80 quick dissolving pellets per tube.

How to dispense pellets? Turn tube upside down. Twist until 5 pellets are dispensed into cap. Carefully remove the cap and use it to pour pellets under the tongue.

Tubes contains approx. 80 pellets, 3.8 g (0.13 oz)

2 Tubes

16 Doses per tube

Year-round sinus relief for colds & allergies

Plant-based actives

Non-drowsy

Formally Sinusalia

Do not use if glued carton and flaps are open or if pellet dispenser seal is broken.

*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 50569-3 (50569-3)

Ask a doctor before use if you have a fever

Section 51727-6 (51727-6)

lactose, sucrose

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

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

BoironUSA.com [email protected]

Distributed by Boiron, Inc. Newtown Square, PA 19073

Made in France

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Belladonna 3C HPUS Relieves sinus pain and stuffy nose*

(contains less than 10 -9 mg atropine alkaloids per pellet)

Sanguinaria canadensis 3C HPUS Relieves sinus pain with runny hose*

(contains less than 10- 8 mg chelidonine alkaloids per pellet)

Spigelia anthelmia 3C HPUS Relieves sinus pain with postnasal drip*

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

Section 55106-9 (55106-9)

Belladonna 3C HPUS (0.14 mg), Sanguinaria canadensis 3C HPUS (0.14 mg), Spigelia anthelmia 3C HPUS(0.14 mg) **

(in each pellet)


Advanced Ingredient Data


Raw Label Data

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