OTC - ACTIVE INGREDIENT SECTION
Active ingredients
Each drop contains: Oryctolagus cuniculus (Rabbit) Spleen 4CH
SPLENINUM
- Manufacturer
- Seroyal USA | SAN'UP
- Effective date
- 2023-10-04
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 4
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 21:25:06
Label at a glance#
ProductSPLENINUM
Active ingredientORYCTOLAGUS CUNICULUS SPLEEN
Label structure12 sections
Label contents#
Full prescribing information#
OTC - PURPOSE SECTION
Uses
Helps to maintain natural resistance and defenses.
Product 'Uses' are based on Homeopathic Materia Medica
and are not supported by clinical trials. These 'Uses' have not
been evaluated by the Food and Drug Administration.
WARNINGS SECTION
Warnings
Stop use and ask a doctor if symptoms persist or worsen.
If pregnant or breastfeeding, ask a health professional
before use. Keep out of reach of children. In case of
overdose, get medical help or contact a Poison Control Center
right away.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children.
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breastfeeding, ask a health professional before use.
OVERDOSAGE SECTION
In case of overdose, get medical help or contact a Poison Control Center right away.
OTC - STOP USE SECTION
Stop use and ask a doctor if symptoms persist or worsen.
OTHER SAFETY INFORMATION
Other information
Do not use if seal is missing or broken.
Store in a cool, dry place.
Contents may not fill package in order to accommodate
required labeling. Please rely on stated quantity
INACTIVE INGREDIENT SECTION
Inactive ingredients Ethanol (beet), purified water
DOSAGE & ADMINISTRATION SECTION
Directions
Adults and adolescents (12 years and older): Take 10 drops 2 to 3 times daily for 3 weeks, then 1
week off and 3 weeks on for 3 months, or as recommended by your healthcare practitioner. Evaluate after 3 months.
Children (under 12 years): Take under the direction of your healthcare practitioner.
INDICATIONS & USAGE SECTION
Uses
Helps to maintain natural resistance and defenses.
Product 'Uses' are based on Homeopathic Materia Medica
and are not supported by clinical trials. These 'Uses' have not
been evaluated by the Food and Drug Administration.
Directions
Adults and adolescents (12 years and older): Take 10 drops 2 to 3 times daily for 3 weeks, then 1
week off and 3 weeks on for 3 months, or as recommended by your healthcare practitioner. Evaluate after 3 months.
Children (under 12 years): Take under the direction of your healthcare practitioner.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 62106-0229-0
UNDA
SPLENINUM
4CH
Homeopathic Remedy
Helps to maintain natural resistance and defenses.
Contains 30% Alcohol
1 fl oz (30 mL)
Products#
Every source-derived product name is available through these pages.
- SPLENINUM
- Oryctolagus cuniculus ( Rabbit) Spleen
- ORYCTOLAGUS CUNICULUS SPLEEN
- ALCOHOL
- WATER
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 62106-0229 | 62106-0229-0 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ORYCTOLAGUS CUNICULUS SPLEEN | 01WNS05SFO | ACTIB |
| ALCOHOL | 3K9958V90M | IACT |
| WATER | 059QF0KO0R | 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 |
|---|---|---|---|---|---|---|
| 06e8a505-7e9a-882c-e063-6394a90aae31 | 7d4f9885-3eed-bd28-e053-2a91aa0a0392 | 2023-10-04 | Warnings | 06e8a505-7e9a-882c-e063-6394a90aae31 7d4f9885-3eed-bd28-e053-2a91aa0a0392 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.