SINUSALIA - atropa belladonna, sanguinaria canadensis root, spigelia anthelmia pellet

United States - English - NLM (National Library of Medicine)

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Active ingredient:
ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H), SANGUINARIA CANADENSIS ROOT (UNII: N9288CD508) (SANGUINARIA CANADENSIS ROOT - UNII:N9288CD508), SPIGELIA ANTHELMIA (UNII: WYT05213GE) (SPIGELIA ANTHELMIA - UNII:WYT05213GE)
Available from:
Laboratoires Boiron
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Temporarily relieves nasal congestion and pain due to the common cold, hay fever or other respiratory allergies. Stop use and ask a doctor if symptoms persist for more than 3 days or worsen.
Product summary:
Approx. 80 pellets each, 3.8g (0.133 oz.)
Authorization status:
unapproved homeopathic
Authorization number:
0220-9343-41

SINUSALIA - atropa belladonna, sanguinaria canadensis root, spigelia anthelmia pellet

Laboratoires Boiron

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for

safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

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Consumer Label Drug Facts

Belladonna 3X, Sanguinaria canadensis 3X, Spigelia anthelmia 3X

Temporarily relieves nasal congestion and pain due to the common cold, hay fever or other respiratory

allergies.

Lactose, Sucrose.

Approx. 80 pellets each, 3.8g (0.133 oz.)

Belladonna 3X

Sanguinaria canadensis 3X

Spigelia anthelmia 3X

Questions, Comments?

1-800-BOIRON-1

(1-800-264-7661)

www.boironusa.com

Boiron Information Center

Newtown Square, PA

19073-3267

Ask a doctor before use:

In children younger than 6 years of age.

If symptoms are accompanied by fever

If you have, or believe you may have, sinusitis.

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

Keep out of reach of children

Do not use if label sealing clear cap is broken

Adults and children 6 years of age and older: Take 5 pellets every 2 hours up to 6 times a day. Allow

pellets to dissolve in the mouth.

Children younger than 6 years of age: Ask a doctor.

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

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SINUSALIA

atropa belladonna, sanguinaria canadensis root, spigelia anthelmia pellet

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:0 220 -9 343

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

ATRO PA BELLADO NNA (UNII: WQZ3G9 PF0 H) (ATROPA BELLADONNA -

UNII:WQZ3G9 PF0 H)

ATROPA BELLADONNA

3 [hp_X]

SANGUINARIA CANADENSIS RO O T (UNII: N9 28 8 CD50 8 ) (SANGUINARIA CANADENSIS

ROOT - UNII:N9 28 8 CD50 8 )

SANGUINARIA

CANADENSIS ROOT

3 [hp_X]

SPIGELIA ANTHELMIA (UNII: WYT0 5213GE) (SPIGELIA ANTHELMIA -

UNII:WYT0 5213GE)

SPIGELIA ANTHELMIA

3 [hp_X]

Laboratoires Boiron

Inactive Ingredients

Ingredient Name

Stre ng th

SUCRO SE (UNII: C151H8 M554)

LACTO SE (UNII: J2B2A4N9 8 G)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:0 220 -9 343-41

8 0 in 1 TUBE

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

unappro ved ho meo pathic

0 9 /0 8 /20 0 8

Labeler -

Laboratoires Boiron (282560473)

Registrant -

Boiron Inc. (014892269)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Labo rato ires Bo iro n

28 256 0 473

ma nufa c ture

Revised: 8/2011

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