Emotional Balance
FDA Label NDC 57520-0386

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 Emotional Balance (NDC 57520-0386). 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 - Active Ingredient

ACTIVE INGREDIENT:  Rauwolfia serpentina 6C, 24C.


Otc - Purpose

INDICATIONS:  For temporary relief of symptoms related to focus and concentration.


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 Poison Control Center right away.


Indications & Usage

INDICATIONS:  For temporary relief of symptoms related to focus and concentration.

Otc - Questions

Manufactured for:

Health and Beyond

7050 W Palmetto Park Rd

#15-554

Boca Raton, FL33433

Package Label.Principal Display Panel

Dr Larry's

EMOTIONAL BALANCE

HOMEOPATHIC

1 FL OZ (30 ML)

Emotional Balance (Mm1)

Emotional Balance (Mm1)


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