SINUSCALM- atropa belladonna, sanguinaria canadensis root, spigelia anthelmia tablet

SINUSCALM by

Drug Labeling and Warnings

SINUSCALM by is a Homeopathic medication manufactured, distributed, or labeled by BOIRON, BOIRON, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

BELLADONNA 3C HPUS (0.8MG), SANGUINARIA CANADENSIS 3C HPUS (0.8 MG) ,SPIGELIA ANTHELMIA 3C HPUS (0.8 MG)**

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*
(contains less than 10 -8 mg alkaloids)

SPIGELIA ANTHELMIA 3C HPUS RELIEVES SINUS PAIN WITH POST NASAL DRIP*

(contains less than 10 -8 mg alkaloids)

INDICATIONS & USAGE

TEMPORARILY RELIEVES NASAL CONGESTION SINUS PAIN HEADACHE DUE TO THE COMMON COLD OR ALLERGIES

WARNINGS

ASK DOCTOR

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

STOP USE

Stop use and ask a doctor if symptoms persist for more than 3 days, worsen or are accompanied by a fever.

PREGNANCY OR BREAST FEEDING

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

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Adults and children 6 years of age and older: At the onset of symptoms, allow 2 tablets to dissolve under the tongue every 2 hours, up to 6 times a day until symptoms are relieved.

Children under 6 years of age: Ask a doctor.

SPL UNCLASSIFIED SECTION

Do not use if glued carton end flaps are open or if the blister seal is broken.

Contains 60 Tablets

Store below 86° F (30° C)

*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.

INACTIVE INGREDIENT

LACTOSE, CROSCARMELLOSE SODIUM, MAGNESIUM STEARATE

QUESTIONS

1-800-BOIRON-1 (1-800-264-7661),
BoironUSA.com Info@boiron.com
Distributed by Boiron, Inc. Newtown Square, PA 19073

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SINUSCALM 
atropa belladonna, sanguinaria canadensis root, spigelia anthelmia tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0220-9338
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H)	ATROPA BELLADONNA	3 [hp_C]
SANGUINARIA CANADENSIS ROOT (UNII: N9288CD508) (SANGUINARIA CANADENSIS ROOT - UNII:N9288CD508)	SANGUINARIA CANADENSIS ROOT	3 [hp_C]
SPIGELIA ANTHELMIA (UNII: WYT05213GE) (SPIGELIA ANTHELMIA - UNII:WYT05213GE)	SPIGELIA ANTHELMIA	3 [hp_C]

Inactive Ingredients
Ingredient Name	Strength
LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
MAGNESIUM STEARATE (UNII: 70097M6I30)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	9mm
Flavor		Imprint Code	Boiron
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0220-9338-04	60 in 1 CARTON; Type 0: Not a Combination Product	06/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		06/01/2019

Labeler - BOIRON (282560473)

Registrant - BOIRON, INC. (014892269)

Establishment
Name	Address	ID/FEI	Business Operations
BOIRON		282560473	manufacture(0220-9338)