Otc - Active Ingredient
ACTIVE INGREDIENTS: Histaminum hydrochloricum 6C, Dopamine 12C, Kidney 12C, L-Theanine 12C, Phenylethylamine hydrochloricum 24C.
Relax
FDA Label NDC 57520-0385
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Apotheca Company for the product Relax (NDC 57520-0385). 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 otc - active ingredient, otc - purpose, warnings, dosage & administration, inactive ingredient, otc - keep out of reach of children, indications & usage, otc - questions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
INDICATIONS: For temporary relief of stress and tension.
Warnings
WARNINGS: Keep out of reach of children. In case of overdose, contact physician or Poison Control Center right away.
If pregnant or breast-feeding, seek advice of a health professional before use.
Tamper seal: "Sealed for Your Protection." Do not use if seal is broken or missing. Store in a cool, dry place.
Dosage & Administration
DIRECTIONS: 2 sprays under tongue three times daily between meals. Consult a physician for use in children under 12 years of age.
Inactive Ingredient
INACTIVE INGREDIENTS: Demineralized water, 20% Ethanol.
Otc - Keep Out Of Reach Of Children
KEEP OUT OF REACH OF CHILDREN. in case of overdose, contact physician or contact Poison Control Center right away.
Indications & Usage
INDICATIONS: For temporary relief of stress and tension.
Otc - Questions
Manufactured for:Health and Beyond7050 W Palmetto Park rd #15-554Boca Raton, FL 33433
Package Label.Principal Display Panel
Dr. Larry"s
RELAX
HOMEOPATHIC
1 FL OZ (30 ml)
Relax (Mm1)
* Please review the disclaimer below.
