Fumaria officinalis
- Manufacturer
- Boiron | Boiron Inc.
- Effective date
- 2023-07-20
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- full-release
- Hydrated at
- 2026-06-01 02:21:54
Label at a glance#
ProductFumaria officinalis
Active ingredientFUMARIA OFFICINALIS FLOWERING TOP
Label structure10 sections
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
Fumaria officinalis 6X
(**contains 0.443 mg of the active ingredient per pellet)
INDICATIONS & USAGE SECTION
Dry skin rash with itching*
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 breast-feeding ask a health professional before use
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children
SPL UNCLASSIFIED SECTION
Do not use if pellet dispenser seal is broken.
Contains approx 80 pellets.
How to dispense pellets? Turn tube upside down. Twist until 5 pellets are dispensed into cap. Carefully remove the cap and use it to pour pellets under the tongue.
*CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED.
*C,K,CK, and X are homeopathic dilutions: see BoironUSA.com/info for details.
INACTIVE INGREDIENT SECTION
lactose, sucrose
DOSAGE & ADMINISTRATION SECTION
Adults and children: At the onset of symptoms, dissolve 5 pellets under the tongue 3 times a day until symptoms are relieved or as directed by a doctor.
OTC - QUESTIONS SECTION
1-800-BOIRON-1 (1-800-264-7661),
BoironUSA.com Info@boiron.com
Distributed by Boiron, Inc. Newtown Square, PA 19073
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 0220-2176-41 | 2023-07-31 | C162847 | 48780-1 | f386c649-fd90-0266-e053-dadaa90a7c1a | Fumaria officinalis 6X |
| 0220-2176-41 | 2023-01-30 | C162847 | 48780-1 | f386c649-fd90-0266-e053-dadaa90a7c1a | Fumaria officinalis 6X |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0220-2176-41 | Fumaria officinalis | 6 [hp_X] in 1 TUBE | PELLET | 6 | 3 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Fumaria officinalis
- FUMARIA OFFICINALIS FLOWERING TOP
- SUCROSE
- LACTOSE, UNSPECIFIED FORM
- ANHYDROUS LACTOSE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 0220-2176 | 0220-2176-41 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| FUMARIA OFFICINALIS FLOWERING TOP | VH659J61ZL | ACTIB |
| SUCROSE | C151H8M554 | IACT |
| LACTOSE, UNSPECIFIED FORM | 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 |
|---|---|---|---|---|---|---|
| Fumaria officinalis | FUMARIA OFFICINALIS FLOWERING TOP | Boiron | 6854cd6f-c910-e59f-e053-2991aa0aea26 | 2023-07-20 | 0220-2176-41 0220-2176 00220217641 00edbc64-9d31-5751-e063-6294a90a400b 6854cd6f-c910-e59f-e053-2991aa0aea26 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.