Dosage and administration
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.
Saponaria officinalis
- Manufacturer
- Laboratoires Boiron | Boiron Inc. | Boiron
- Effective date
- 2023-11-14
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 4
- Source
- full-release
- Hydrated at
- 2026-06-01 02:24:32
Label at a glance#
ProductSaponaria officinalis
Active ingredientSAPONARIA OFFICINALIS ROOT
Label structure9 sections
Label contents#
Full prescribing information#
Active Ingredients
Saponaria officinalis 6X
(**contains 0.443 mg of the active ingredient per pellet)
Use
Skin rash with itching*
Warnings
Stop use and ask a doctor if
symptoms persist for more than 3 days or worsen.
If pregnant or breast-feeding,
ask a health professional before use.
Keep out of reach of children.
Directions
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.
Other information
Do not use if pellet dispenser seal is broken.
contains approx. 80 pellets
Inactive ingredients
lactose, sucrose
Questions, Comments?
1-800-BOIRON-1
Newtown Square, PA 19073-3267
info@boironusa.com
*
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.
Principle Display Panel - Saponaria officinalis HPUS 6X
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 0220-4562-41 | 2023-11-14 | C162847 | 48780-1 | f386c64a-0853-0266-e053-dadaa90a7c1a | Saponaria officinalis 6X |
| 0220-4562-41 | 2023-01-30 | C162847 | 48780-1 | f386c64a-0853-0266-e053-dadaa90a7c1a | Saponaria officinalis 6X |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0220-4562-41 | Saponaria officinalis | 80 in 1 TUBE | PELLET | 80 | 4 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Saponaria officinalis
- SAPONARIA OFFICINALIS ROOT
- SUCROSE
- LACTOSE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 0220-4562 | 0220-4562-41 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| SUCROSE | C151H8M554 | IACT |
| LACTOSE | J2B2A4N98G | IACT |
| SAPONARIA OFFICINALIS ROOT | RI2K1BMA8B | ACTIB |
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 |
|---|---|---|---|---|---|---|
| Saponaria officinalis | SAPONARIA OFFICINALIS ROOT | Laboratoires Boiron | fa34daf0-7c73-11e6-899c-424c58303031 | 2023-11-14 | Warnings | 0220-4562-41 0220-4562 00220456241 0a24b8af-5223-c47e-e063-6294a90a2787 fa34daf0-7c73-11e6-899c-424c58303031 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.