FDA.reportPublic FDA data

Arnica Advantage

Manufacturer
Genexa Inc.
Effective date
2020-12-21
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
legacy-cache
Hydrated at
2026-08-01 23:00:39

Label at a glance#

ProductArnica Advantage
Active ingredientTOXICODENDRON PUBESCENS LEAF, ARNICA MONTANA, CALENDULA OFFICINALIS FLOWERING TOP, LEDUM PALUSTRE TWIG, RUTA GRAVEOLENS FLOWERING TOP
Label structure15 sections

Storage and handling

Other information store between 15-30°C (59-86°F) in a dry place out of direct sunlight.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

KEEP OUTER PACKAGE FOR COMPLETE PRODUCT INFORMATION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredients‡** (in each tablet)

Arnica montana 30X HPUS

Calendula officinalis 6X HPUS

Ledum palustre 6X HPUS

Rhus toxicodendron 12X HPUS

Ruta graveolens 6X HPUS

‡ Certified Organic

"HPUS" indicates that this ingredient is officially included in the Homeopathic Pharmacopoeia of the United States.

OTC - PURPOSE SECTION

Purpose

trauma, muscle pain, muscle soreness, stiffness, swelling, bruising, strains and sprains

cuts, scrapes and discoloration from bruising

swelling, stiffness and bruising

joint pain, joint soreness and joint stiffness

muscle pain and muscle soreness

INDICATIONS & USAGE SECTION

Uses*

  • addresses muscle pain and stiffness due to minor injuries, overexertion and falls.
  • addresses pain, swelling and discoloration from bruises.

WARNINGS SECTION

Warnings

OTC - STOP USE SECTION

Stop use and ask a doctor if symptoms persist for more than 3 days or worsen.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breastfeeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

DOSAGE & ADMINISTRATION SECTION

Directions

adults and children 12 years of age

and older

  • chew 2 tablets at the onset of symptoms
  • do not swallow whole
  • repeat every 4-6 hours as needed
children 3-11 years of age
  • chew 1 tablet at the onset of symptoms
  • do not swallow whole
  • repeat every 4-6 hours as needed
children under 3 years of ageask a doctor before use

STORAGE AND HANDLING SECTION

Other information

  • store between 15-30°C (59-86°F) in a dry place out of direct sunlight.

INACTIVE INGREDIENT SECTION

Inactive ingredients

organic carnauba wax, organic compliant natural flavor, organic dextrose, organic maltodextrin, organic rice bran extract

SPL UNCLASSIFIED SECTION

* CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE, NOT ACCEPTED MEDICAL EVIDENCE. Not FDA evaluated.

** X is a homeopathic dilution: see www.genexa.com for more information.

Patent Pending

SPL UNCLASSIFIED SECTION

Distributed by: Genexa Inc.

Los Angeles, CA 90034

www.genexa.com

Certified Organic by SCS Global Services

BOTTLE IS SAFETY SEALED. DO NOT USE IF BOTTLE SEAL IS DISTURBED OR MISSING.

SPL UNCLASSIFIED SECTION

Questions? Comments?

1-855-GENEXA-1

hello@genexa.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Genexa®

THE HEALTHIER MEDICINE®

NDC 69676-0031-2

ARNICA ADVANTAGE TM

ORGANIC PAIN RELIEF FORMULA*

  • 5 INGREDIENTS FOR PAIN
  • Muscle Pain & Soreness*
  • Joint Pain & Stiffness*
  • Bruises & Swelling*

100 CHEWABLE TABLETS

HOMEOPATHIC

GRAPE FLAVOR

Arnica20200127Arnica20200127

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69676-003169676-0031-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
TOXICODENDRON PUBESCENS LEAF6IO182RP7AACTIB
ARNICA MONTANAO80TY208ZWACTIB
CALENDULA OFFICINALIS FLOWERING TOP18E7415PXQACTIB
LEDUM PALUSTRE TWIG877L01IZ0PACTIB
RUTA GRAVEOLENS FLOWERING TOPN94C2U587SACTIB
CARNAUBA WAXR12CBM0EIZIACT
MALTODEXTRIN7CVR7L4A2DIACT
RICE BRANR60QEP13ICIACT
DEXTROSEIY9XDZ35W2IACT

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
b700b50d-d3bd-91fe-e053-2a95a90a881d2eddd2ce-72be-34fe-e054-00144ff8d46c2020-12-21WarningsExact identifier
spl id: b700b50d-d3bd-91fe-e053-2a95a90a881d
spl set id: 2eddd2ce-72be-34fe-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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