Relaxatone Liquid
FDA Label NDC 44911-0077

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Energique, Inc. for the product Relaxatone (NDC 44911-0077). 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 active ingredients, indications, warnings, directions, inactive ingredients, keep out of reach of children, indications and usage, questions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Passiflora Incarnata 3X, Scutellaria Lateriflora 3X, Valeriana Officinalis 3X, Arsenicum album 12X, Calcarea Carbonica 12X, Coffea Cruda 12X, Ignatia Amara 12X, Kali Phosphoricum 12X, Lycopus Virginicus 12X, Staphysagria 12X

Indications

For temporary relief of anxiety and stress. 

**These statements are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.

Warnings

If pregnant or breast-feeding, 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.

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

Directions

Adults and children 5 to 10 drops orally, 3 times daily or as otherwise directed by a health care professional. If symptoms persist, consult your health care professional. Consult a physician for use in children under 12 years of age.

Inactive Ingredients

Demineralized water, 20% Ethanol.

Keep Out Of Reach Of Children

In case of overdose, get medical help or contact a Poison Control Center right away.

Indications And Usage

For temporary relief of anxiety and stress.

**These statements are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.

Questions

Dist. by Energique, Inc.

201 Apple Blvd

Woodbine, IA 51579

800-869-8078

Package Label.Principal Display Panel

ENERGIQUE

since 1987

HOMEOPATHIC REMEDY

RELAXATONE

1 fl. oz. (30 ml)

* Please review the disclaimer below.