Valerianaheel
FDA Label NDC 50114-1165

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Heel Inc for the product Valerianaheel (NDC 50114-1165). 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 keep out of reach of children, indications and usage, warnings, dosage and administration, active ingredient, inactive ingredient, purpose, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Keep Out Of Reach Of Children

Keep this and all medicines out of the reach of children.

Indications And Usage

For the temporary relief of:
  • Sleeplessness
  • Restlessness
  • Nervous tension and exhaustion


Warnings

If symptoms persist or worsen, a physician should be consulted. As with any drug, if you are pregnant or nursing a baby, seek the advise of a health care professional before using this product.

Dosage And Administration

Adults and children above 11 years: 10 drops orally, 3 times daily, or as directed by a physician. Consult a physician for use in children under 12 years of age.

Active Ingredient

Each 50 ml contains as active ingredients: Valeriana officinalis 2X 32.5 ml; Picricum acidum 6X 5 ml; Prunus spinosa 2X 2.5 ml; Humulus lupulus 2X 2.5 ml; Hypericum perforatum 3X 2.5 ml; Melissa officinalis 2X 1.5 ml; Avena sativa 2X 1 ml; Chamomilla 2X 1 ml; Ammonium bromatum 2X 0.5 ml; Kali bromatum 2X 0.5 ml; Natrum bromatum 2X 0.5 ml.

Inactive Ingredient

Inactive ingredients: Ethanol, Purified Water USP.

Purpose

Sleeplessness, Restlessness, Nervous tension and exhaustion

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