Arnica Montana

Manufacturer
NARTEX LABORATORIOS HOMEOPATICOS SA DE CV
Effective date
2025-08-13
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
full-release
Hydrated at
2026-06-01 02:34:40

Label at a glance#

ProductArnica Montana
Active ingredientARNICA MONTANA
Label structure14 sections

Storage and handling

Store at room temperature. Do not use if container seal is broken.

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Arnica montana......6C HPUS

OTC - PURPOSE SECTION

Arnica montana.......6C HPUS*......anti-inflammatory

*The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States. "C" indicates a homeopathic dilution. See www.nartexlabsusa.com for more information.

INDICATIONS & USAGE SECTION

For the temporary relief of:

  • sore muscles
  • bruises
  • sprains

Claims based on traditional homeopathic practice, not accepted medical evidence. These uses have not been evaluated by FDA, and product has not been clinically tested.

WARNINGS SECTION

Do not use

  • if you have an allergy or hypersensitivity to the components of the formula.
  • more than the maximum daily dosage unless directed by a doctor.

OTC - STOP USE SECTION

Stop use and ask a doctor if:

  • condition worsens
  • a rash develops
  • symptoms persist for more than 7 days or clear up and return within a few days

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast feeding, consult a health professional.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Directions

  • Allow pellets to dissolve slowly in the mouth.
  • Adults and children over 4 years of age: take 3 pellets orally every 6 hours.
  • Children under 4 years of age: consult a doctor.

STORAGE AND HANDLING SECTION

  • Store at room temperature.
  • Do not use if container seal is broken.

INACTIVE INGREDIENT SECTION

Sucrose

OTC - QUESTIONS SECTION

Questions or comments?informacion@nartexlabs.comor call 1-877-248-1970 between 9am and 5pm CST

DESCRIPTION SECTION

Active ingredients are prepared in accordance with the Homeopathic Pharmacopoeia of the United States, and are therefore non-toxic and have no known side effects.

Keep box. It contains important information. See the package insert.

DESCRIPTION SECTION

Distributed by:

Nartex Labs USA, Inc.

9543 Bissonnet St. Ste. 302

Houston TX 77036 USA

www.nartexlabsusa.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 34666-091-50

Arnica

Nartex

Pellets

For Sore muscles and bruises

Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated and not clinically tested.

Homeopathic

150 pellets

11

22

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
34666-091-50Arnica Montana150 in 1 BOTTLE, GLASSPELLET1509

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ARNICA MONTANAACTIVE INGREDIENTO80TY208ZW1
ARNICA MONTANAACTIVE MOIETYO80TY208ZW1
SUCROSEINACTIVE INGREDIENTC151H8M5541

Products#

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

DailyMed product names page 1 of 1 · 2 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
34666-09134666-091-50

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
SUCROSEC151H8M554IACT
ARNICA MONTANAO80TY208ZWACTIB

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 2 · 62 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
SUCROSESUCROSEC151H8M554GRANULE / ORALNAExact identifier — unii+route
62 equally ranked IID candidates
SUCROSESUCROSEC151H8M554LIQUID / ORAL37500 mgExact identifier — unii+route
62 equally ranked IID candidates
SUCROSESUCROSEC151H8M554ELIXIR / ORAL18000 mgExact identifier — unii+route
62 equally ranked IID candidates
SUCROSESUCROSEC151H8M554CAPSULE, DELAYED RELEASE / ORAL955 mgExact identifier — unii+route
62 equally ranked IID candidates
SUCROSESUCROSEC151H8M554TABLET, COATED / ORAL516.42 mgExact identifier — unii+route
62 equally ranked IID candidates
SUCROSESUCROSEC151H8M554TABLET, FILM COATED / ORAL145 mgExact identifier — unii+route
62 equally ranked IID candidates
SUCROSESUCROSEC151H8M554SOLUTION / ORAL70000 mgExact identifier — unii+route
62 equally ranked IID candidates
SUCROSESUCROSEC151H8M554TABLET, DELAYED RELEASE / ORAL295.33 mgExact identifier — unii+route
62 equally ranked IID candidates
SUCROSESUCROSEC151H8M554CAPSULE / ORAL3568 mgExact identifier — unii+route
62 equally ranked IID candidates
SUCROSESUCROSEC151H8M554TROCHE / ORALNAExact identifier — unii+route
62 equally ranked IID candidates
SUCROSESUCROSEC151H8M554SUSPENSION, EXTENDED RELEASE / ORAL5400 mgExact identifier — unii+route
62 equally ranked IID candidates
SUCROSESUCROSEC151H8M554GRANULE, FOR SUSPENSION / ORAL31885 mgExact identifier — unii+route
62 equally ranked IID candidates
SUCROSESUCROSEC151H8M554CAPSULE, COATED, EXTENDED RELEASE / ORAL86 mgExact identifier — unii+route
62 equally ranked IID candidates
SUCROSESUCROSEC151H8M554POWDER, FOR SOLUTION / ORAL38666 mgExact identifier — unii+route
62 equally ranked IID candidates
SUCROSESUCROSEC151H8M554TABLET / ORAL4249 mgExact identifier — unii+route
62 equally ranked IID candidates
SUCROSESUCROSEC151H8M554CONCENTRATE / ORAL4800 mgExact identifier — unii+route
62 equally ranked IID candidates
SUCROSESUCROSEC151H8M554TABLET, FILM COATED, EXTENDED RELEASE / ORAL119.12 mgExact identifier — unii+route
62 equally ranked IID candidates
SUCROSESUCROSEC151H8M554CAPSULE, EXTENDED RELEASE / ORAL619 mgExact identifier — unii+route
62 equally ranked IID candidates
SUCROSESUCROSEC151H8M554TABLET, DELAYED RELEASE / ORAL295.33 mgExact identifier — unii+route
62 equally ranked IID candidates
SUCROSESUCROSEC151H8M554WAFER / ORAL155.2 mgExact identifier — unii+route
62 equally ranked IID candidates
SUCROSESUCROSEC151H8M554SUSPENSION/ DROPS / ORAL3750 mgExact identifier — unii+route
62 equally ranked IID candidates
SUCROSESUCROSEC151H8M554GRANULE / ORALNAExact identifier — unii+route
62 equally ranked IID candidates
SUCROSESUCROSEC151H8M554POWDER / ORAL27768 mgExact identifier — unii+route
62 equally ranked IID candidates
SUCROSESUCROSEC151H8M554DROPS / ORALNAExact identifier — unii+route
62 equally ranked IID candidates
SUCROSESUCROSEC151H8M554TABLET, EXTENDED RELEASE / ORAL284.54 mgExact identifier — unii+route
62 equally ranked IID candidates
SUCROSESUCROSEC151H8M554TABLET, EXTENDED RELEASE / ORAL284.54 mgExact identifier — unii+route
62 equally ranked IID candidates
SUCROSESUCROSEC151H8M554GRANULE, FOR SUSPENSION / ORAL31885 mgExact identifier — unii+route
62 equally ranked IID candidates
SUCROSESUCROSEC151H8M554PASTILLE / ORAL426 mgExact identifier — unii+route
62 equally ranked IID candidates
SUCROSESUCROSEC151H8M554DROPS / ORALNAExact identifier — unii+route
62 equally ranked IID candidates
SUCROSESUCROSEC151H8M554GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL18790 mgExact identifier — unii+route
62 equally ranked IID candidates
SUCROSESUCROSEC151H8M554SUSPENSION/ DROPS / ORAL3750 mgExact identifier — unii+route
62 equally ranked IID candidates
SUCROSESUCROSEC151H8M554TROCHE / ORALNAExact identifier — unii+route
62 equally ranked IID candidates
SUCROSESUCROSEC151H8M554TABLET, CHEWABLE / ORAL7258 mgExact identifier — unii+route
62 equally ranked IID candidates
SUCROSESUCROSEC151H8M554GRANULE, FOR SOLUTION / ORAL42596 mgExact identifier — unii+route
62 equally ranked IID candidates
SUCROSESUCROSEC151H8M554LIQUID / ORAL37500 mgExact identifier — unii+route
62 equally ranked IID candidates
SUCROSESUCROSEC151H8M554TABLET, COATED / ORAL516.42 mgExact identifier — unii+route
62 equally ranked IID candidates
SUCROSESUCROSEC151H8M554CAPSULE, EXTENDED RELEASE / ORAL619 mgExact identifier — unii+route
62 equally ranked IID candidates
SUCROSESUCROSEC151H8M554CAPSULE, COATED PELLETS / ORAL59.8 mgExact identifier — unii+route
62 equally ranked IID candidates
SUCROSESUCROSEC151H8M554CAPSULE, DELAYED RELEASE / ORAL955 mgExact identifier — unii+route
62 equally ranked IID candidates
SUCROSESUCROSEC151H8M554SYRUP / ORAL46400 mgExact identifier — unii+route
62 equally ranked IID candidates
SUCROSESUCROSEC151H8M554SYRUP / ORAL46400 mgExact identifier — unii+route
62 equally ranked IID candidates
SUCROSESUCROSEC151H8M554POWDER / ORAL27768 mgExact identifier — unii+route
62 equally ranked IID candidates
SUCROSESUCROSEC151H8M554TABLET, FILM COATED / ORAL145 mgExact identifier — unii+route
62 equally ranked IID candidates
SUCROSESUCROSEC151H8M554CONCENTRATE / ORAL4800 mgExact identifier — unii+route
62 equally ranked IID candidates
SUCROSESUCROSEC151H8M554TABLET / ORAL4249 mgExact identifier — unii+route
62 equally ranked IID candidates
SUCROSESUCROSEC151H8M554GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL18790 mgExact identifier — unii+route
62 equally ranked IID candidates
SUCROSESUCROSEC151H8M554SUSPENSION, EXTENDED RELEASE / ORAL5400 mgExact identifier — unii+route
62 equally ranked IID candidates
SUCROSESUCROSEC151H8M554TABLET, CHEWABLE / ORAL7258 mgExact identifier — unii+route
62 equally ranked IID candidates
SUCROSESUCROSEC151H8M554SUSPENSION / ORAL48209 mgExact identifier — unii+route
62 equally ranked IID candidates
SUCROSESUCROSEC151H8M554ELIXIR / ORAL18000 mgExact identifier — unii+route
62 equally ranked IID candidates
SUCROSESUCROSEC151H8M554CAPSULE, COATED, EXTENDED RELEASE / ORAL86 mgExact identifier — unii+route
62 equally ranked IID candidates
SUCROSESUCROSEC151H8M554POWDER, FOR SUSPENSION / ORAL40017 mgExact identifier — unii+route
62 equally ranked IID candidates
SUCROSESUCROSEC151H8M554PASTILLE / ORAL426 mgExact identifier — unii+route
62 equally ranked IID candidates
SUCROSESUCROSEC151H8M554CAPSULE / ORAL3568 mgExact identifier — unii+route
62 equally ranked IID candidates
SUCROSESUCROSEC151H8M554SUSPENSION / ORAL48209 mgExact identifier — unii+route
62 equally ranked IID candidates
SUCROSESUCROSEC151H8M554WAFER / ORAL155.2 mgExact identifier — unii+route
62 equally ranked IID candidates
SUCROSESUCROSEC151H8M554POWDER, FOR SOLUTION / ORAL38666 mgExact identifier — unii+route
62 equally ranked IID candidates
SUCROSESUCROSEC151H8M554TABLET, FILM COATED, EXTENDED RELEASE / ORAL119.12 mgExact identifier — unii+route
62 equally ranked IID candidates
SUCROSESUCROSEC151H8M554CAPSULE, COATED PELLETS / ORAL59.8 mgExact identifier — unii+route
62 equally ranked IID candidates
SUCROSESUCROSEC151H8M554POWDER, FOR SUSPENSION / ORAL40017 mgExact identifier — unii+route
62 equally ranked IID candidates

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
Arnica MontanaARNICA MONTANANARTEX LABORATORIOS HOMEOPATICOS SA DE CV3c62d081-4178-4ac0-b81f-d97202dee8ea2025-08-13WarningsExact identifier
ndc (package): 34666-091-50
ndc (product): 34666-091
ndc11 (package): 34666009150
spl id: 3c46848d-23e8-a387-e063-6394a90a83e8
spl set id: 3c62d081-4178-4ac0-b81f-d97202dee8ea

Reported adverse events (FAERS/openFDA)#

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