ROXALIA- arnica montana, arisaema triphyllum root, belladonna leaf, bromine, bryonia alba root, mercurius solubilis, phytolacca americana root, pulsatilla vulgaris, spongia officinalis skeleton, roasted tablet

Roxalia by

Drug Labeling and Warnings

Roxalia 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

Arnica montana 3C, Arum triphyllum 3C, Belladonna 3C, Bromium 3C, Bryonia alba 3C, Mercuris solubilis 4C, Phytolacca decandra 3C, Pulsatilla 3C, Spongia tosta 3C

PURPOSE

Arnica montana 3C Relieves hoarseness due to overexertion of the vocal cords
Arum triphyllum 3C Relieves vocal cord fatigue in speakers and singers
Belladonna 3C Relieves red and sore throat
Bromium 3C Relieves swollen and painful tonsils
Bryonia alba 3C Relieves sore throat with intense thirst
Mercuris solubilis 4C Relieves sore throat with intense salivation
Phytolacca decandra 3C Relieves sore throat with pain spreading to the ears
Pulsatilla 3C Relieves raw sore throat
Spongia tosta 3C Relieves hoarseness with dry throat

INDICATIONS & USAGE

Temporary relieves minor sore throat and hoarseness.

STOP USE

Stop use and ask a doctor if symptoms persist continuously for more than 2 days or worsen.

ASK DOCTOR

Ask a doctor before use in children younger than 12 years of age.

If sore throat is severe, accompanied or followed by fever, headache, rash nausea or vomiting.

WHEN USING

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

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

DOSAGE & ADMINISTRATION

Adults and children 12 years of age and older: At the onset of symptoms, dissolve 2 tablets under the tongue every 15 minutes for 1 hour. Then, dissolve 2 tablets under the tongue 3 times a day until symptoms are relieved.
Children under 12 years of age: Ask a doctor.

STORAGE AND HANDLING

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

INACTIVE INGREDIENT

Croscarmellose sodium, lactose, magnesium stearate.

QUESTIONS

Questions, Comments
www.boironusa.com
info@boironusa.com

1-800-BOIRON-1
(1-800-264-7661)
Distributed by Boiron Inc.
6 campus boulevard
Newtown Square, PA
19073-3267

HOW SUPPLIED

60 tablets

WARNINGS

PRINCIPAL DISPLAY PANEL

Roxalia image

INGREDIENTS AND APPEARANCE

ROXALIA 
arnica montana, arisaema triphyllum root, belladonna leaf, bromine, bryonia alba root, mercurius solubilis, phytolacca americana root, pulsatilla vulgaris, spongia officinalis skeleton, roasted tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0220-9321
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW)	ARNICA MONTANA	3 [hp_C]
ARISAEMA TRIPHYLLUM ROOT (UNII: DM64K844DM) (ARISAEMA TRIPHYLLUM ROOT - UNII:DM64K844DM)	ARISAEMA TRIPHYLLUM ROOT	3 [hp_C]
BELLADONNA LEAF (UNII: 6GZW20TIOI) (BELLADONNA LEAF - UNII:6GZW20TIOI)	BELLADONNA LEAF	3 [hp_C]
BROMINE (UNII: SBV4XY874G) (BROMINE - UNII:SBV4XY874G)	BROMINE	3 [hp_C]
BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B)	BRYONIA ALBA ROOT	3 [hp_C]
MERCURIUS SOLUBILIS (UNII: 324Y4038G2) (MERCURIUS SOLUBILIS - UNII:324Y4038G2)	MERCURIUS SOLUBILIS	4 [hp_C]
PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG) (PHYTOLACCA AMERICANA ROOT - UNII:11E6VI8VEG)	PHYTOLACCA AMERICANA ROOT	3 [hp_C]
PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV)	PULSATILLA VULGARIS	3 [hp_C]
SPONGIA OFFICINALIS SKELETON, ROASTED (UNII: 1PIP394IID) (SPONGIA OFFICINALIS SKELETON, ROASTED - UNII:1PIP394IID)	SPONGIA OFFICINALIS SKELETON, ROASTED	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: 0220-9321-04	60 in 1 BLISTER PACK; Type 0: Not a Combination Product	10/01/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		10/01/2013

Labeler - Laboratoires Boiron (282560473)

Registrant - Boiron Inc. (014892269)

Establishment
Name	Address	ID/FEI	Business Operations
Boiron		282560473	manufacture(0220-9321)