FDA.reportPublic FDA data

Arnica Montana 6X

Manufacturer
Schwabe Mexico, S.A. de C.V.
Effective date
2020-10-12
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 02:13:24

Label at a glance#

ProductArnica Montana 6X
Active ingredientARNICA MONTANA
Label structure11 sections

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Arnica montana 6X

Inactive Ingredients

INACTIVE INGREDIENT SECTION

CELLULOSE

LACTOSE MONOHYDRATE

MAGNESIUM STEARATE

SODIUM CROSCARMELLOSE

Dosage & Administration

DOSAGE & ADMINISTRATION SECTION

Dosage:

Adults or children over 2 years: Take 3 tablets 4-6 times a day.

Allow to dissolve under tongue.

Indications

INDICATIONS & USAGE SECTION

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

Purpose

OTC - PURPOSE SECTION

For the temporary relief of minor muscle or joint aches and pain; strains, sprains, bruises, backache or overexertion.

Warning

WARNINGS SECTION

Warning: Do not take this product for pain for more than 10 days for adults or 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 and Breast Feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

Keep Out of Reach of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Overdosage

OVERDOSAGE SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Arnica montana 6X-21103534_5.jpgArnica montana 6X-21103534_5.jpg

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68466-1043ARNICA MONTANA 6X (ARNICA MONTANA) TABLET [SCHWABE MEXICO, S.A. DE C.V.]4Legacy NDC20201013_88d3995e-9101-46c2-a4c9-12e7ab718c82.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
68466-104368466-1043-2

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
d58e6d89-ba28-4961-b136-3235edceabe888d3995e-9101-46c2-a4c9-12e7ab718c822020-10-12WarningsExact identifier
spl id: d58e6d89-ba28-4961-b136-3235edceabe8
spl set id: 88d3995e-9101-46c2-a4c9-12e7ab718c82

Reported adverse events (FAERS/openFDA)#

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