The following Structured Product Label (SPL) was submitted to the FDA by Energique, Inc. for the product Relaxatone (NDC 44911-0640). 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:, keep out of reach of children:, directions:, inactive ingredients:, questions:, package label display:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
(in each drop): 14.24% of Arsenicum Album 12X, Calcarea Carbonica 12X, Coffea Cruda 12X, Ignatia Amara 12X, Kali Phosphoricum 12X, Lycopus Virginicus 12X, Staphysagria 12X; 0.10% of Passiflora Incarnata 3X, Scutellaria Lateriflora 3X, Valeriana Officinalis 3X.
May temporarily relieve anxiety and stress.
**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.
May temporarily relieve anxiety and stress.
**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.
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.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Adults and children 5 to 10 drops orally, 3 times daily or as otherwise directed by a health care professional. If symptoms persist for more than 7 days, consult your health care professional. Consult a physician for use in children under 12 years of age.
Demineralized water, 20% Ethanol.
Dist. by Energique, Inc.
201 Apple Blvd
Woodbine, IA 51579
800-869-8078
ENERGIQUE
SINCE 1987
HOMEOPATHIC REMEDY
RELAXATONE
2 fl. oz. (60 ml)
* Please review the disclaimer below.
