Fears And Nightmares
FDA Label NDC 57955-5099

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 Fears And Nightmares (NDC 57955-5099). 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, inactive ingredient, warnings, otc - keep out of reach of children, dosage & administration, other safety information, indications & usage, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

HPUS active ingredients: ​Aconitum napellus, Aurum bromatum, Calcarea carbonica, Chamomilla, Cina, Ignatia amara, Kali bromatum, Lycopodium clavatum, Paeonia officinalis, Phosphorus, Stramonium, Sulphur. Equal volumes of each ingredient in 10X, 30X, LM1 potencies.

Otc - Purpose

Uses​ a natural aid for: frightening dreams, night terrors, crying, talking or screaming in sleep, restless tossing, anxiety, jerking, twitching, waking up terrified, general fears day or night, phobias.

Inactive Ingredient

Inactive Ingredients:

Bio-Energetically Enhanced™ pure water base, Citric acid and Potassium sorbate.

Warnings

Warning

  • Stop use and ask a doctor. If symptoms persist or worsen.
  • If pregnant or breast-feeding, ask a healthcare professional before use.

Otc - Keep Out Of Reach Of Children

  • Keep out of reach of children

Dosage & Administration

Directions

  • Initially, depress pump until primed.
  • Spray one dose directly into mouth.
  • Ages 12 and up 3 sprays 3 times per day.
  • Ages 2-12 2 sprays 3 times per day.

Other Safety Information

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

Indications & Usage

Uses ​a natural aid for:

  • frightening dreams
  • night terrors
  • crying, talking or screaming in sleep
  • restless tossing
  • anxiety, jerking, twitching, waking up terrified
  • general fears day or night
  • phobias

* Please review the disclaimer below.