Arnica 30X Tablets

Manufacturer
Boiron | Boiron Inc.
Effective date
2023-09-29
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:22:25

Label at a glance#

ProductARNICA
Active ingredientARNICA MONTANA
Label structure11 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

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.

OTC - PURPOSE SECTION

Purpose*

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

INDICATIONS & USAGE SECTION

Uses*

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

OTC - STOP USE SECTION

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.

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

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 SECTION

croscarmellose sodium, lactose, magnesium stearate

OTC - QUESTIONS SECTION

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.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0220-9089-04ARNICA60 in 1 BLISTER PACKTABLET601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0220-9089ARNICA (ARNICA MONTANA) TABLET [BOIRON]1Current NDC, 1 package rows20231001_0682b0ee-eebb-c149-e063-6294a90a6293.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0220-90890220-9089-04

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ARNICAARNICA MONTANABoiron0682b0ee-eebb-c149-e063-6294a90a62932023-09-29Exact identifier
ndc (package): 0220-9089-04
ndc (product): 0220-9089
ndc11 (package): 00220908904
spl id: 0682b0ee-eebc-c149-e063-6294a90a6293
spl set id: 0682b0ee-eebb-c149-e063-6294a90a6293

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.