Indications and uses
Bruises, Aches, Pains
ARNICA MONTANA
- Manufacturer
- Rxhomeo Private Limited d.b.a. Rxhomeo, Inc | Rxhomeo, Inc
- Effective date
- 2015-12-30
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-06-01 02:07:27
Label at a glance#
ProductARNICA MONTANA
Active ingredientARNICA MONTANA
Label structure9 sections
Storage and handling
Store in a cool dark place
Contacts and useful links#
Websitewww.rxhomeo.com
www.Rxhomeo.com
www.Rxhomeo.comLabel contents#
Full prescribing information#
ACTIVE INGREDIENT
ARNICA MONTANA HPUS 3X and Higher
USES
Bruises, Aches, Pains
INDICATIONS
Condition listed above or as directed by the physician
DOSAGE
Adults- Take 4 or 6 Tablets by mouth, three times daily or as suggested by physician. Children 2 years and older- take 1/2 the adult dose.
WARNINGS
This product is to be used for self-limiting conditions
OTC - STOP USE SECTION
If symptoms do not improve in 4 days, or worsen, discontinue use and seek assistance of health professional
OTC - PREGNANCY OR BREAST FEEDING SECTION
As with any drug, if you are pregnant, or nursing a baby, seek professional advice before taking this product
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep this and all medication out of reach of children
OTC - DO NOT USE SECTION
Do not use if capseal is broken or missing.
Close the cap tightly after use.
INACTIVE INGREDIENTS
Lactose
STORAGE
Store in a cool dark place
QUESTIONS OR COMMENTS
www.Rxhomeo.com | 1.888.2796642 | info@rxhomeo.com
Rxhomeo, Inc 9415 Burnet Road, Suite 312, Austin, TX 78758
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 15631-0521-0 | 2020-01-31 | C162847 | 48780-1 | 9d75b9cf-fcf2-f424-e053-dadaa90a57ce | b78deba7-3132-4efc-af07-997bda1d8cd7 |
| 15631-0521-1 | 2020-01-31 | C162847 | 48780-1 | 9d75b9cf-fcf2-f424-e053-dadaa90a57ce | b78deba7-3132-4efc-af07-997bda1d8cd7 |
| 15631-0521-2 | 2020-01-31 | C162847 | 48780-1 | 9d75b9cf-fcf2-f424-e053-dadaa90a57ce | b78deba7-3132-4efc-af07-997bda1d8cd7 |
| 15631-0521-3 | 2020-01-31 | C162847 | 48780-1 | 9d75b9cf-fcf2-f424-e053-dadaa90a57ce | b78deba7-3132-4efc-af07-997bda1d8cd7 |
| 15631-0521-4 | 2020-01-31 | C162847 | 48780-1 | 9d75b9cf-fcf2-f424-e053-dadaa90a57ce | b78deba7-3132-4efc-af07-997bda1d8cd7 |
| 15631-0521-5 | 2020-01-31 | C162847 | 48780-1 | 9d75b9cf-fcf2-f424-e053-dadaa90a57ce | b78deba7-3132-4efc-af07-997bda1d8cd7 |
| 15631-0521-6 | 2020-01-31 | C162847 | 48780-1 | 9d75b9cf-fcf2-f424-e053-dadaa90a57ce | b78deba7-3132-4efc-af07-997bda1d8cd7 |
| 15631-0521-7 | 2020-01-31 | C162847 | 48780-1 | 9d75b9cf-fcf2-f424-e053-dadaa90a57ce | b78deba7-3132-4efc-af07-997bda1d8cd7 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 15631-0521-0 | ARNICA MONTANA | 1 in 1 BLISTER PACK | TABLET | 1 | 1 | |
| 15631-0521-1 | ARNICA MONTANA | 4 in 1 BLISTER PACK | TABLET | 4 | 1 | |
| 15631-0521-2 | ARNICA MONTANA | 50 in 1 CONTAINER | TABLET | 50 | 1 | |
| 15631-0521-3 | ARNICA MONTANA | 100 in 1 CONTAINER | TABLET | 100 | 1 | |
| 15631-0521-4 | ARNICA MONTANA | 250 in 1 CONTAINER | TABLET | 250 | 1 | |
| 15631-0521-5 | ARNICA MONTANA | 500 in 1 CONTAINER | TABLET | 500 | 1 | |
| 15631-0521-6 | ARNICA MONTANA | 1000 in 1 CONTAINER | TABLET | 1000 | 1 | |
| 15631-0521-7 | ARNICA MONTANA | 10000 in 1 CONTAINER | TABLET | 10000 | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 15631-0521 | ARNICA MONTANA TABLET [RXHOMEO PRIVATE LIMITED D.B.A. RXHOMEO, INC] | 1 | Legacy NDC, 8 package rows | 20160111_b78deba7-3132-4efc-af07-997bda1d8cd7.zip |
Products#
Every source-derived product name is available through these pages.
- ARNICA MONTANA
- LACTOSE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 15631-0521 | 15631-0521-0, 15631-0521-1, 15631-0521-2, 15631-0521-3, 15631-0521-4, 15631-0521-5, 15631-0521-6, 15631-0521-7 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ARNICA MONTANA | O80TY208ZW | ACTIB |
| LACTOSE | J2B2A4N98G | IACT |
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 625e0a3a-55c7-4a85-a516-606c3ad60ed0 | b78deba7-3132-4efc-af07-997bda1d8cd7 | 2015-12-30 | Warnings | 625e0a3a-55c7-4a85-a516-606c3ad60ed0 b78deba7-3132-4efc-af07-997bda1d8cd7 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.