Calm
FDA Label NDC 66579-0049

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by New Sun Inc. for the product Calm (NDC 66579-0049). 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.

Label Section Quick Index

Dosage & Administration

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

Warnings

Warnings: If symptoms persist or worsen, seek advice of physician. If pregnant or breast-feeding, take only on advice of physician.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Other Safety Information

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

Otc - Purpose

Indications: For temporary relief of: stress induced states such as: •nervous tension •minor anxieties •fearfulness •over-sensitivity

Otc - Active Ingredient

Active Ingredients: ​Aconitum napellus, Alfalfa, Argentum nitricum, Avena sativa, Chamomilla, Gelsemium sempervirens, Glonoinum, Histaminum hydrochloricum, Ignatia amara, Kali phosphoricum, Passiflora incarnata, Phosphorus, Veratrum album. ​Equal volumes of each ingredient in 10X, 30X, 1LM potencies.

Inactive Ingredient

Inactive Ingredient: Citric acid, potassium sorbate, purified water.

Indications & Usage

Indications: For temporary relief of: stress induced states such as:

  • nervous tension
  • minor anxiety
  • fearfulness
  • over-sensitivity

    • For promoting:

    • calm
    • confidence

* Please review the disclaimer below.