Hendel Insomnia Relief
FDA Label NDC 62795-1120

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Medinatura Inc for the product Hendel Insomnia Relief (NDC 62795-1120). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding warnings, active ingredient, inactive ingredient, directions, keep out of reach of children, uses, purpose, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Warnings

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

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

Lactose, Magnesium stearate

Directions

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

KEEP OUT OF REACH OF CHILDREN

Uses

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

Purpose

Insomnia Relief

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