Kids Stress And Anxiety
FDA Label NDC 57955-0423

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 Kids Stress And Anxiety (NDC 57955-0423). 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, indications & usage, warnings, otc - keep out of reach of children, dosage & administration, other safety information, inactive ingredient, otc - purpose, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Otc - Active Ingredient

Drug Facts​__________________________________________________________________________________________________________

HPUS active ingredients: ​Aconitum napellus, Aethusa cynapium, Alfalfa, Aurum metallicum, Avena sativa, Baryta carbonica, Chamomilla, Ignatia amara, Impatiens glandulifera, flos, Kali phosphoricum, Laurocerasus, Natrum phosphoricum, Passiflora incarnata, Phosphorus, Prunus cerasifera, flos, Staphysagria, Stramonium. Equal volumes of each ingredient in 10X, 30X, LM1 potencies.

Indications & Usage

Uses ​for temporary relief of symptoms:

  • stress
  • minor anxiety
  • fear
  • irritability
  • nervousness
  • agitation
  • mood swings
  • worry
  • restlessness
  • nervous stomach
  • oversensitivity
  • whining
  • emotional overexcitement
  • performance anxiety
  • anger
  • difficulty concentrating
  • inconsolable
  • overwhelmed
  • as per various homeopathic materia medicas. These uses have not been evaluated by the FDA, and product has not been clinically tested.

Warnings

Warnings

  • Stop use and consult a doctor if symptoms worsen or persist for more than 7 days (3 days for children under 2).
  • Keep out of reach of children.
  • As with any drug, consult a doctor before use if pregnant or nursing.

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.
  • 2 to 6 years: 2 sprays every 15 minutes, up to 4 doses, then hourly until relieved.
  • 6 to 12 Years: 2 sprays, every 15 minutes, up to 8 doses, then hourly until relieved.
  • 12 years & older: 3 sprays, every 15 minutes, up to 8 doses, then hourly until relieved.

Other Safety Information

Other information

This product is intended to complement, not replace, standard medical care. • Tamper resistant for your protection. Use only if safety seal is intact.

Inactive Ingredient

Inactive Ingredients:

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

Otc - Purpose

Drug Facts_________________________________________________________________________________________________

HPUS* active ingredients                                      Purpose†

Equal volumes of each ingredient in 10X, 30X, and LM1 potencies.

Aconitum napellus........................................emotional overexcitement

Aethusa cynapium.....................................................inability to focus

Alfalfa..............................................................gloominess, irritability

Aurum metallicum.................................overstimulated, noise-sensitive

Avena sativa....................................................difficulty concentrating

Baryta carbonica........................................confusion, loss of confidence

Chamomilla.......................................oversensitivity, whining, agitation

Ignatia amara....................................................mood changes, worry

Impatiens glandulifera, flos.............................overwhelmed, impatient

Kali phosphoricum.............................................startles easily, anxiety

Laurocerasus...................................................anger if misunderstood

Natrum phosphoricum.................................................nighttime fears

Passiflora incarnata..................................................nervous stomach

Phosphorus..............................................performance anxiety, stress

Prunus cerasifera, flos..................................anxiousness, restlessness

Staphysagria.....................................................irritable nervousness

Stramonium..............................................mood swings, inconsolable

*"HPUS" indicates the active ingredients are in the official Homeopathic Pharmacopeia of the United States.

* Please review the disclaimer below.