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.