ARNICA- arnica montana pellet

Arnica by

Drug Labeling and Warnings

Arnica 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 30C HPUS
(**contains 0.443 mg of the active ingredient per pellet)

PURPOSE

Relieves muscle pain & stiffness, swelling from injuries, discoloration from bruises*

INDICATIONS & USAGE

temporarily relieves muscle pain and stiffness due to minor injuries, overexeration and falls, reduces pain, swelling and discoloration from bruises

WARNINGS

STOP USE

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

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.

DO NOT USE

Do not use if the label sealing the clear tube cap is broken or missing.

DOSAGE & ADMINISTRATION

Adults and children: At the onset of symptoms, dissolve 5 pellets under the tongue 3 times a day until symptoms are relived or as directed by a doctor.

INACTIVE INGREDIENT

lactose, sucrose.

SPL UNCLASSIFIED SECTION

Pain Relief"

Non Drowsy, No Known Drug Interactions, On-the-Go Pain Relief, Non-Habit Forming

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.

3 Tubes approx 80 quick dissolving pellets per tube

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

*Claims are 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.

Arnica Montana has been used for centuries as a natural pain reliever. Today, it has grown to be one of the most popular homeopathic medicines throughout the world. Arnica is trusted by professional athletes to relieve sore muscles, by prominent plastic surgeons to ease post-procedure pain, and by savvy moms to treat playground bumps and bruises.

QUESTIONS

Questions, Comments?

www.arnicare.com

www.boiron.com

1-800-BOIRON-1

(1-800-264-7661)

Distributed by Boiron Inc.
Newtown Square, PA 19073-3267

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ARNICA 
arnica montana pellet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0220-0508
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW)	ARNICA MONTANA	30 [hp_C]

Inactive Ingredients
Ingredient Name	Strength
SUCROSE (UNII: C151H8M554)
LACTOSE (UNII: J2B2A4N98G)

Product Characteristics
Color	white	Score	no score
Shape	ROUND (Pellet)	Size	4mm
Flavor		Imprint Code	;
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0220-0508-43	3 in 1 PACKAGE	05/01/2009
1	NDC: 0220-0508-41	80 in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 0220-0508-41	80 in 1 TUBE; Type 0: Not a Combination Product	05/01/2009

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		05/01/2009

Labeler - Laboratoires Boiron (282560473)

Registrant - Boiron Inc. (014892269)

Establishment
Name	Address	ID/FEI	Business Operations
Boiron		282560473	manufacture(0220-0508)