The following Structured Product Label (SPL) was submitted to the FDA by New Sun Inc. for the product Stress And Anxiety (NDC 66579-0018). 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 dosage & administration, warnings, otc - keep out of reach of children, other safety information, otc - purpose, otc - active ingredient, inactive ingredient, indications & usage, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Directions: Before initial dose depress pump 4-5 times or until primed and spray 1 dose directly in mouth 4 to 6 times daily until symptoms improve.
Adult Dose: 3 Pump Sprays
Child's Dose (2-12): 2 Pump Sprays
Infants - 2 yrs: 1 Pump Sprays
Warnings:If symptoms persist or worsen, seek advice of physician. If pregnant or breast-feeding, take only on advice of physician.
Keep out of reach of children.
Other information: Tamper resistant for your protection. Use only if safety seal is intact.
Indications: For temporary relief of: •nervous tension •minor anxieties •fearfulness •oversenaitivity
Active Ingredients: Aconitum napellus, Apis mellifica, Arnica montana, Arsenicum album, Belladonna, Bellis perennis, Bryonia, Calendula officinalis, Chamomilla, Cistus canadensis, Clematis erecta, Ferrum phosphoricum, Histaminum hydrochloricum, Hypericum perforatum, Ignatia amara, Impatiens glandulifera, flos, Ornithogalum umbellatum, Passiflora incarnata, Phosphorus, Prunus cerasifera, flos, Rhus toxicodendron, Sulphur, Symphytum officinale, Veratrum album. Equal volumes of each ingredient in 10X, 30X, 100X potencies.
Inactive Ingredient: Citric acid, potassium sorbate, purified water.
Indications: For temporary relief of:
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