ARNICA- arnica montana tablet

ARNICA by

Drug Labeling and Warnings

ARNICA by is a Homeopathic medication manufactured, distributed, or labeled by Boiron, Boiron Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients** (in each tablet)

Arnica montana 30X HPUS (2.5 mg)

The letters HPUS indicate that the component in this product is officially monographed in the Homeopathic Pharmacopoeia of the United States.

PURPOSE

Purpose*

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

INDICATIONS & USAGE

Uses*

temporarily relieves muscle pain and stiffness due to: minor injuries overexertion falls
reduces symptoms of bruising such as: pain swelling discoloration

WARNINGS

STOP USE

Stop use and ask a doctor if symptoms persist for more than 7 days or worsen, new symptoms occur, or if redness or swelling is present. These could be signs of a serious condition.

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 overdose, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Adults and children 6 years for age and older - At the onset of symptoms, dissolve 2 tablets in the mouth and repeat every hour for 2 more hours. Then, dissolve 2 tablets in the mouth every 6 hours until symptoms are relieved.

Children 2 to 5 years of age: Dissolve 2 tablets in 1 tablespoon of water for easier intake. Follow directions above.

Children under 2 years of age: Ask a doctor.

INACTIVE INGREDIENT

croscarmellose sodium, lactose, magnesium stearate

QUESTIONS

Questions or comments?

Arnicare.com

BoironUSA.com

Info@Boiron.com

1-800-BOIRON-1

(1-800-264-7661)

Made in France

Distributed by Boiron Inc.

Newtown Square, PA 19073

SPL UNCLASSIFIED SECTION

do not use if glued carton ends flaps are open or if the blister seal is broken

store below 86°F (30°C)

PAIN RELIEF*

Swelling & Bruises from Injuries Muscle Pain*

60 Meltaway Tablets, unflavored

Gentle on the stomach

NSAID-Free

No Known Drug Interactions

Non-Drowsy

Meltaway Tablets Require No Food or Water

*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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ARNICA 
arnica montana tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0220-9089
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_X]

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

Product Characteristics
Color	white	Score	score with uneven pieces
Shape	ROUND (Boiron)	Size	9mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0220-9089-04	60 in 1 BLISTER PACK; Type 0: Not a Combination Product	10/01/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		10/01/2023

Labeler - Boiron (282560473)

Registrant - Boiron Inc. (014892269)

Establishment
Name	Address	ID/FEI	Business Operations
Boiron		282560473	manufacture(0220-9089)