FDA Label for Kids Stress And Anxiety

View Indications, Usage & Precautions

Kids Stress And Anxiety Product Label

The following document was submitted to the FDA by the labeler of this product King Bio Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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.