FDA.reportPublic FDA data

HYPOTHALAMUS

Manufacturer
Seroyal USA | SAN'UP
Effective date
2022-11-07
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 21:49:28

Label at a glance#

ProductHYPOTHALAMUS
Active ingredientORYCTOLAGUS CUNICULUS HYPOTHALAMUS
Label structure11 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Each Drop Contains: Oryctolagus cuniculus
(Rabbit) Hypothalamus 4CH

OTC - PURPOSE SECTION

Helps to promote a restful sleep pattern
and support even-temperamented
behaviour in kids.

WARNINGS SECTION

Warnings

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. If symptoms persist or worsen, consult your healthcare practitioner.

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.

OTHER SAFETY INFORMATION

If symptoms persist or worsen, consult your healthcare practitioner.

Do not use if seal is missing or broken. Store in a cool, dry place.

INACTIVE INGREDIENT SECTION

Inactive ingredients: Ethanol (beet), purified water

DOSAGE & ADMINISTRATION SECTION

Directions Adults and Children (over 12 years): Take 10 drops two to three times daily.

Children (1-12 years): Take three to five drops two to three times daily.

Take for three weeks, then one week off and three weeks on for three months, or as recommended

by your healthcare practitioner. Evaluate after three months.

INDICATIONS & USAGE SECTION

Indications

Helps to promote a restful sleep pattern
and support even-temperamented
behaviour in kids.

Directions Adults and Children (over 12 years): Take 10 drops two to three times daily.

Children (1-12 years): Take three to five drops two to three times daily.

Take for three weeks, then one week off and three weeks on for three months, or as recommended

by your healthcare practitioner. Evaluate after three months.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 62106-0212-0
HYPOTHALAMUS
4CH
Homeopathic
Remedy
Contains
30% Alcohol
1 fl oz (30 ml)

62106-0212-062106-0212-0

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
62106-021262106-0212-0

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
ORYCTOLAGUS CUNICULUS HYPOTHALAMUSQMH532G890ACTIB
ALCOHOL3K9958V90MIACT
WATER059QF0KO0RIACT

Source Document#

Source XML

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
07600453-0b6e-65ed-e063-6294a90a21837d4f8624-575e-b2b8-e053-2991aa0a402e2023-10-10WarningsExact identifier
spl set id: 7d4f8624-575e-b2b8-e053-2991aa0a402e

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.