FDA.reportPublic FDA data

Arnica Montana 30X

Manufacturer
Schwabe Mexico S.A. de C.V.
Effective date
2020-12-22
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
legacy-cache
Hydrated at
2026-08-01 23:00:35

Label at a glance#

ProductArnica Montana 30X
Active ingredientARNICA MONTANA
Label structure11 sections

Dosage and administration

Dosage: Adults or children over 2 years: Take 3 tablets 1 to 3 times a day. Allow to dissolve under tongue.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Arnica montana 30X

Inactive Ingredients

INACTIVE INGREDIENT SECTION

CELLULOSE

LACTOSE MONOHYDRATE

MAGNESIUM STEARATE

SODIUM CROSCARMELLOSE

Dosage and Administration

DOSAGE & ADMINISTRATION SECTION

Dosage:
Adults or children over 2 years: Take 3 tablets 1 to 3 times a day.

Allow to dissolve under tongue.

Purpose

OTC - PURPOSE SECTION

Temporarily relieves minor muscle or joint aches and pain from strains, sprains, bruises, backache, overexertion.

Indications & Usage 

INDICATIONS & USAGE SECTION

Uses temporarily relieves minor muscle or joint aches and pains, strains, sprians, bruises, backache, overexertion

Warning

WARNINGS SECTION

Do not use this product for pain for more than 10 days (for adults) and 5 days (for children) unless directed by a doctor.

When using 

OTC - WHEN USING SECTION

When using this product, if pain persists or gets worse, if new symptoms occur, or if redness or swelling is present, consult a doctor because these could be signs of a serious condition.

Pregnancy or breast feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

Overdose

OVERDOSAGE SECTION

In case of overdose, seek medical help or contact a Posion Control Center immediately.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Arnica Montana_30X_21103574_04.jpgArnica Montana_30X_21103574_04.jpg

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68466-1042ARNICA MONTANA 30X (ARNICA MONTANA) TABLET [SCHWABE MEXICO S.A. DE C.V.]6Legacy NDC20201223_6ec399ba-722e-46e2-a84f-3c757d0fdd41.zip

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68466-104268466-1042-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
ARNICA MONTANAO80TY208ZWACTIB
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
LACTOSE MONOHYDRATEEWQ57Q8I5XIACT
MAGNESIUM STEARATE70097M6I30IACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT

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
b761eb18-d7fd-4067-8d84-bb0b4c1b52686ec399ba-722e-46e2-a84f-3c757d0fdd412020-12-22WarningsExact identifier
spl id: b761eb18-d7fd-4067-8d84-bb0b4c1b5268
spl set id: 6ec399ba-722e-46e2-a84f-3c757d0fdd41

Reported adverse events (FAERS/openFDA)#

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