Hendel Insomnia Relief

Manufacturer
MediNatura Inc
Effective date
2023-02-16
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 02:20:05

Label at a glance#

ProductHendel Insomnia Relief
Active ingredientPASSIFLORA INCARNATA FLOWERING TOP, AMBERGRIS, SCUTELLARIA LATERIFLORA, ZINC VALERATE DIHYDRATE, ANAMIRTA COCCULUS SEED, ARABICA COFFEE BEAN
Label structure8 sections

Indications and uses

For the temporary relief of: • Occasional Nervous Restlessness • Occasional Sleeplessness • Frequent Awakening

Dosage and administration

Adults 18 and over: 1 to 2 tablets sublingually or dissolved completely in mouth 30 to 60 minutes before going to bed or as directed by a physician.

Label contents#

Full prescribing information#

WARNINGS

WARNINGS SECTION

If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. If sleeplessness persists continuously for more than 2 weeks, consult your doctor. Insomnia may be a symptom of serious underlying medical illness. Do not use if sensitivity to Insomnia Relief or any of its ingredients exists. In case of accidental overdose, contact a Poison Control Center immediately.

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Each tablet contains equal parts of Passiflora incarnata 2X; Amber grisea 6X; Scutellaria lateriflora 6X; Zincum valerianicum 6X; Cocculus indicus 12X; Coffea cruda 12X

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

Lactose, Magnesium stearate

Directions

DOSAGE & ADMINISTRATION SECTION

Adults 18 and over: 1 to 2 tablets sublingually or dissolved completely in mouth 30 to 60 minutes before going to bed or as directed
by a physician.

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN

Uses

INDICATIONS & USAGE SECTION

For the temporary relief of:
• Occasional Nervous Restlessness
• Occasional Sleeplessness
• Frequent Awakening

PURPOSE

OTC - PURPOSE SECTION

Insomnia Relief

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Hendel Insomnia ReliefHendel Insomnia Relief

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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62795-1120-2Hendel Insomnia Relief100 in 1 BOTTLETABLET1004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62795-1120HENDEL INSOMNIA RELIEF (PASSIFLORA INCARNATA FLOWERING TOP, AMBERGRIS, SCUTELLARIA LATERIFLORA, ZINC VALERATE DIHYDRATE, ANAMIRTA COCCULUS SEED, AND ARABICA COFFEE BEAN) TABLET [MEDINATURA INC]4Legacy NDC, 1 package rows20230217_565298ba-ce51-48d0-b6a4-d4d6c40f2b9e.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62795-1120-2EA - Each62795-11201b576dbf-b504-43d8-8bbf-101a0bfe82dc12023-03-13

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
62795-112062795-1120-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

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
c5912419-63fa-417f-acd2-8b9b49ff5e29565298ba-ce51-48d0-b6a4-d4d6c40f2b9e2023-02-16WarningsExact identifier
spl id: c5912419-63fa-417f-acd2-8b9b49ff5e29
spl set id: 565298ba-ce51-48d0-b6a4-d4d6c40f2b9e

Reported adverse events (FAERS/openFDA)#

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