Hendel Homeopathic Calm

Manufacturer
MediNatura Inc
Effective date
2022-08-22
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 02:18:03

Label at a glance#

ProductHendel Homeopathic Calm
Active ingredientAVENA SATIVA FLOWERING TOP, MATRICARIA CHAMOMILLA, HOPS, PASSIFLORA INCARNATA FLOWERING TOP, ZINC VALERATE DIHYDRATE, ARABICA COFFEE BEAN, STRYCHNOS NUX-VOMICA SEED, SULFUR
Label structure8 sections

Indications and uses

For the temporary relief of: • Restlessness • Occasional simple nervous tension

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 symptoms persist or worsen, a health professional should be consulted. Do not use if sensitivity to Homeopathic Calm or any of its ingredients exists. In case of accidental overdose, contact a Poison Control Center immediately

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN

INDICATIONS

OTC - PURPOSE SECTION

Restlessness Occasional and simple nervous tension

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

Each tablet contains equal parts of Avena sativa 2X; Chamomilla 2X; Humulus lupulus 2X; Passiflora incarnata 2X; Zincum valerianicum 6X; Coffea cruda 12X; Nux vomica 12X; Sulphur 12X

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

Lactose, Magnesium stearate

DOSAGE

DOSAGE & ADMINISTRATION SECTION

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

USES

INDICATIONS & USAGE SECTION

For the temporary relief of:
• Restlessness
• Occasional simple nervous tension

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Hendel Homeopathic CalmHendel Homeopathic Calm

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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62795-1118-2Hendel Homeopathic Calm100 in 1 BOTTLETABLET1003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62795-1118HENDEL HOMEOPATHIC CALM (AVENA SATIVA FLOWERING TOP, MATRICARIA CHAMOMILLA, HOPS, PASSIFLORA INCARNATA FLOWERING TOP, ZINC VALERATE DIHYDRATE, ARABICA COFFEE BEAN, STRYCHNOS NUX-VOMICA SEED, AND SULFUR) TABLET [MEDINATURA INC]3Legacy NDC, 1 package rows20220823_3f87c276-9676-4935-b541-24ef84b6e9cc.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62795-1118-2EA - Each62795-1118a7a2e6fa-7e17-4cd3-941d-d3c07259ce9412018-05-09

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
62795-111862795-1118-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 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
e1c0ca8c-7465-4e50-bf67-ea9b15560ce23f87c276-9676-4935-b541-24ef84b6e9cc2022-08-22WarningsExact identifier
spl id: e1c0ca8c-7465-4e50-bf67-ea9b15560ce2
spl set id: 3f87c276-9676-4935-b541-24ef84b6e9cc

Reported adverse events (FAERS/openFDA)#

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