ARNICA MONTANA (Whole Plant)

Manufacturer
Remedy Makers
Effective date
2023-03-23
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 02:20:36

Label at a glance#

ProductARNICA MONTANA (Whole Plant)
Active ingredientARNICA MONTANA
Label structure13 sections

Dosage and administration

Dissolve 3 or 4 pellets in mouth or under tongue 3 times a day or as directed by a physician. Children 2 years and older take 1/2 adult dose.

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

ARNICA MONTANA 200C

(WHOLE PLANT)

OTC - PURPOSE SECTION

BRUISES AND MUSCLE SORENESS, OR OTHER INDICATIONS

WARNING:

WARNINGS SECTION

"The FDA has not determined that this product is safe, effective and not misbranded for its intended use."

INDICATIONS & USAGE SECTION

To be used according to standard homeopathic indications for self-limiting conditions such as those indicated above or as directed by a physician.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep this and all medication out of reach of children.

Warning:

WARNINGS SECTION

Use only if cap and seal are unbroken. If symptoms persist for more than 3 days or worsen, discontinue (STOP) use and consult your physician. As with any drug, if you are pregnant or nursing (breast-feeding) a baby, seek the advise of a health professional before using this product. Store tightly closed in a cool area.

Directions (adult/children)

DOSAGE & ADMINISTRATION SECTION

Dissolve 3 or 4 pellets in mouth or under tongue 3 times a day or as directed by a physician. Children 2 years and older take 1/2 adult dose.

Other Information:

HOW SUPPLIED SECTION

Contains approx. 164-169 pellets.

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Lactose and Sucrose. Free from yeast, wheat, corn and soy.

Questions or comments

OTC - QUESTIONS SECTION

(877) REM4YOU Fax (909) 594-4205 Pomona, CA 91768. USA

INDICATIONS & USAGE SECTION

Free from yeast, wheat, corn, and soy.
DIRECTIONS: Dissolve 3 or 4 pellets
in mouth or under tongue 3 times a day or as directed by a physician.
Children 2 years and older take 1/2
adult dose.
INDICATIONS: To be used according
to standard homeopathic indications
for self limiting conditions such as
those indicated on the front panel or as directed by a physician.
Warnings: *Use only if cap and
seal are unbroken. * Keep this and all medications out of reach of children.
* If symptoms persist for more then 3
days, consult your physician.
*As with any drug, if your are pregnant or nursing a baby, seek the advice of a
health professional before using this product.*Store tightly closed in a cool, dark place.
Made according to The Homeopathic Pharmacopoeia of the United States by: Remedy Makers, Pomona, CA 91768

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Sample LabelSample Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ARNICA MONTANA 200CARNICA MONTANA 200C

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10191-1255-2ARNICA MONTANA (Whole Plant)171 in 1 VIAL, GLASSPELLET1718

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10191-1255ARNICA MONTANA (WHOLE PLANT) (ARNICA WHOLE PLANT) PELLET [REMEDY MAKERS]8Legacy NDC, 1 package rows20230325_f695dfe4-3103-450a-aeef-8ea420e78df2.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ARNICA MONTANAACTIVE INGREDIENTO80TY208ZW7
ARNICA MONTANAACTIVE MOIETYO80TY208ZW7

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
10191-125510191-1255-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 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
f7984dd0-4cdc-ef02-e053-6394a90a5a60f695dfe4-3103-450a-aeef-8ea420e78df22023-03-23WarningsExact identifier
spl id: f7984dd0-4cdc-ef02-e053-6394a90a5a60
spl set id: f695dfe4-3103-450a-aeef-8ea420e78df2

Reported adverse events (FAERS/openFDA)#

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