Arnica Montana by Pharmaca Integrative Pharmacy / Boiron, Inc. / Boiron Inc. ARNICA MONTANA pellet

Arnica Montana by

Drug Labeling and Warnings

Arnica Montana by is a Homeopathic medication manufactured, distributed, or labeled by Pharmaca Integrative Pharmacy, Boiron, Inc., Boiron Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

ACTIVE INGREDIENT: Arnica Montana 30 C

PURPOSE

INDICATIONS & USAGE

USES: Muscle aches and stiffness, swelling from injuries, discoloration from bruising*

WARNINGS

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

STOP USE

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.

DOSAGE & ADMINISTRATION

DIRECTIONS (Adults/Children): Dissolve 5 pellets in the mouth every 2 hours up to 6 times a day. Decrease frequency with improvement.

DO NOT USE

OTHER INFORMATION: Do not used if pellet dispenser seal is broken.

STORAGE AND HANDLING

INACTIVE INGREDIENT

INACTIVE INGREDIENTS: lactose, sucrose

HOW SUPPLIED

CONTENTS: Approx. 80 pellets, 3.8 g (0.133 oz).

SPL UNCLASSIFIED SECTION

*These uses have not been evaluated by the FDA.

Manufactured exclusively for Pharama Integrative Pharmacy, Inc. Boulder, Colorado 80301 www.pharmaca.com

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ARNICA MONTANA 
arnica montana pellet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62082-100
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
Shape	ROUND	Size	4mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62082-100-83	80 in 1 TUBE; Type 0: Not a Combination Product	02/01/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		02/01/2014

Labeler - Pharmaca Integrative Pharmacy (031903446)

Registrant - Boiron, Inc. (014892269)

Establishment
Name	Address	ID/FEI	Business Operations
Boiron Inc.		014892269	manufacture(62082-100)