SPLENINUM (oryctolagus cuniculus- rabbit spleen liquid

SPLENINUM by

Drug Labeling and Warnings

SPLENINUM by is a Homeopathic medication manufactured, distributed, or labeled by Seroyal USA, SAN'UP. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients

Each drop contains: Oryctolagus cuniculus (Rabbit) Spleen 4CH

PURPOSE

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

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.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

PREGNANCY OR BREAST FEEDING

If pregnant or breastfeeding, ask a health professional before use.

OVERDOSAGE

In case of overdose, get medical help or contact a Poison Control Center right away.

STOP USE

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

Inactive ingredients Ethanol (beet), purified water

DOSAGE & 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.

INDICATIONS & USAGE

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.

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)

INGREDIENTS AND APPEARANCE

SPLENINUM 
oryctolagus cuniculus ( rabbit) spleen liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62106-0229
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ORYCTOLAGUS CUNICULUS SPLEEN (UNII: 01WNS05SFO) (ORYCTOLAGUS CUNICULUS SPLEEN - UNII:01WNS05SFO)	ORYCTOLAGUS CUNICULUS SPLEEN	4 [hp_C]  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62106-0229-0	30 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	12/18/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		12/18/2018

Labeler - Seroyal USA (018361118)

Establishment
Name	Address	ID/FEI	Business Operations
SAN'UP		401010287	manufacture(62106-0229)