Burnout
FDA Label NDC 57955-0980

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by King Bio Inc. for the product Burnout (NDC 57955-0980). 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 warnings, otc - keep out of reach of children, dosage & administration, other safety information, otc - active ingredient, otc - purpose, inactive ingredient, indications & usage, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Warnings

Warnings

  • Stop use and ask your doctor if symptoms persist or worsen.
  • If pregnant or breast-feeding, take only on advice of a healthcare professional.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children

Dosage & Administration

  • Initially, depress pump until primed.
  • Spray one dose directly into mouth.
  • Adults: 3 sprays 3 times per day.
  • Children (2-12 years): 2 sprays 3 times per day.
  • Children (1 month-2 years): 1 spray 3 times per day.

Other Safety Information

Tamper resistant for your protection. Use only if safety seal is intact.

Otc - Active Ingredient

HPUS active ingredients: Alfalfa, Ambra grisea, Anacardium orientale, Argentum nitricum, Aurum metallicum, Avena sativa, Caladium seguinum, Calcarea carbonica, Cocculus indicus, Gelsemium sempervirens, Ignatia amara, Kali phosphoricum, Lycopodium clavatum, Natrum muriaticum, Nux vomica, Phosphoricum acidum, Phosphorus, Selenium metallicum, Sepia, Silicea, Sulphur. Equal volumes of each ingredient in 10X, 30X, 100X, LM1, LM2, LM3, LM5 potencies.​

Otc - Purpose

Uses temporarily relieves symptoms due to fatigue: headaches, drowsiness, inability to fall asleep, sweet food cravings, sudden drain of energy, nausea.

Inactive Ingredient

Inactive Ingredients:

Bio-Energetically Enhanced™ pure water, citric acid and potassium sorbate.

Indications & Usage

Uses temporarily relieves symptoms due to fatigue:

  • headaches
  • drowsiness
  • inability to fall asleep
  • sweet food cravings
  • sudden drain of energy
  • nausea

Package Label.Principal Display Panel

Image Description (Burnout)

Image Description (Burnout)

* Please review the disclaimer below.