SINUSALIA- belladonna leaf, sanguinaria canadensis root, spigelia tablet

Sinusalia by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT

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

INDICATIONS & USAGE

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

INACTIVE INGREDIENT

Croscarmellose sodium, lactose, magnesium stearate.

HOW SUPPLIED

60 tablets

PURPOSE

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

STORAGE AND HANDLING

Store at 68-77 o  F (20-25 o C)

QUESTIONS

Questions, Comments
www.boironusa.com
info@boironusa.com
1-800-BOIRON-1 (1-800-264-7661)
Boiron Information Center
6 campus Bouelvard
Newtown Square, PA
19073-3267

ASK DOCTOR

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

If symptoms are accompanied by fever.

STOP USE

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

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

PREGNANCY OR BREAST FEEDING

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

WHEN USING

DRUG INTERACTIONS

Non drowsy, no drug interactions

WARNINGS

Do not use if blister seal is broken

DOSAGE & 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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SINUSALIA 
belladonna leaf, sanguinaria canadensis root, spigelia tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0220-9341
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BELLADONNA LEAF (UNII: 6GZW20TIOI) (BELLADONNA LEAF - UNII:6GZW20TIOI)	BELLADONNA LEAF	3 [hp_C]
SANGUINARIA CANADENSIS ROOT (UNII: N9288CD508) (SANGUINARIA CANADENSIS ROOT - UNII:N9288CD508)	SANGUINARIA CANADENSIS ROOT	3 [hp_C]
SPIGELIA MARILANDICA ROOT (UNII: 467D26HS0B) (SPIGELIA MARILANDICA ROOT - UNII:467D26HS0B)	SPIGELIA MARILANDICA ROOT	3 [hp_C]

Inactive Ingredients
Ingredient Name	Strength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
LACTOSE (UNII: J2B2A4N98G)
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: 0220-9341-04	60 in 1 BLISTER PACK; Type 0: Not a Combination Product	04/01/2011

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		04/01/2011

Labeler - Laboratoires Boiron (282560473)

Registrant - Boiron Inc. (014892269)

Establishment
Name	Address	ID/FEI	Business Operations
Boiron		282560473	manufacture(0220-9341)