Websitewww.remedymakers.com
www.remedymakers.com
www.remedymakers.comSYMPHYTUM OFFICINALE
- Manufacturer
- REMEDY MAKERS
- Effective date
- 2011-12-27
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-06-01 02:03:29
Label at a glance#
ProductSYMPHYTUM OFFICINALE
Active ingredientCOMFREY LEAF
Label structure8 sections
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - PURPOSE SECTION
BONE TRAUMA, PROMOTES HEALING OF FRACTURES, OR OTHER INDICATIONS
OTC - ACTIVE INGREDIENT SECTION
COMFREY LEAF
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
WARNING:Keep this and all medications out of reach of children.
INDICATIONS & USAGE SECTION
INDICATIONS: To be use according to standard
homeopathic indications, for self-limiting conditions such as these
indicated above or as directed by a physician.
WARNINGS SECTION
WARNING: 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.
DOSAGE & ADMINISTRATION SECTION
Directions:(adult/children)
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 the adult
dose.
INACTIVE INGREDIENT SECTION
Inactive Ingredient: Lactose and Sucrose. Free from yeast, wheat, corn and soy.
OTC - QUESTIONS SECTION
Questions or comments.(877)REM4YOU. Fax (909)594-4205 Pomona, CA. 91768. USA www.remedymakers.com
Other information: Contain approx.152 - 155 pellets.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 10191-1603-2 | 2019-11-13 | C162847 | 48780-1 | 97449f38-b5b5-f6ea-e053-dbdaa90aa703 | SYMPHYTUM OFFICINALE 12C (Comfrey Plant) |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 10191-1603-2 | SYMPHYTUM OFFICINALE | 152 in 1 VIAL, GLASS | PELLET | 152 | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 10191-1603 | SYMPHYTUM OFFICINALE (COMFREY PLANT) PELLET [REMEDY MAKERS] | 1 | Legacy NDC, 1 package rows | 20111228_51502cd3-917c-4a4b-8bbc-7c1f4120d799.zip |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| COMFREY LEAF | ACTIVE INGREDIENT | DG4F8T839X | 1 | |
| COMFREY LEAF | ACTIVE MOIETY | DG4F8T839X | 1 |
Products#
Every source-derived product name is available through these pages.
- SYMPHYTUM OFFICINALE
- COMFREY PLANT
- COMFREY LEAF
- SUCROSE
- LACTOSE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 10191-1603 | 10191-1603-2 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| COMFREY LEAF | DG4F8T839X | ACTIB |
| SUCROSE | C151H8M554 | IACT |
| 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 |
|---|---|---|---|---|---|---|
| 07c407e9-1537-402a-8360-95d7c4ec7502 | 51502cd3-917c-4a4b-8bbc-7c1f4120d799 | 2011-12-27 | Warnings | 07c407e9-1537-402a-8360-95d7c4ec7502 51502cd3-917c-4a4b-8bbc-7c1f4120d799 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.