Sleep Aid
FDA Label NDC 57955-5639

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 Sleep Aid (NDC 57955-5639). 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 active ingredients, inactive ingredient, dosage and administration, warnings, purpose, indications and usage, otc - keep out of reach of children, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Active Ingredients

Drug Facts

HPUS active ingredients

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

Aconitum napellus, Arsenicum album, Avena sativa, Belladonna, Camphora, Cinchona officinalis, Coffea cruda, Cypripedium pubescens, Hyoscyamus niger, Ignatia amara, Passiflora incarnata, Pulsatilla, Valeriana officinalis. 

HPUS Flower remedy

Aesculus hippocastanum, flos


Inactive Ingredient

Bio-Energetically Enhanced taste free, pure water base


Dosage And Administration

Directions Initially, depress pump until primed. Hold close to mouth and spray one dose directly into mouth.

Adult dose: 3 pump sprays 3 times per day. Use additionally as needed.

Children: 2-12 years 2 pump sprays 3 times per day. Use additionally as needed.


Warnings

If symptoms persist or worsen, or if pregnant or nursing, take only on advice of a healthcare professional. Keep out of reach of children.

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


Purpose

HPUS active ingredients                   Purpose

Aconitum napellus...................................fear, worry

Arsenicum album....................................anguish, fears

Avena sativa..........................................nervous exhaustion

Belladonna.............................................restlessness

Camphora.............................................restless tossing

Cinchona officinalis.................................anxious dreams, early waking

Coffea cruda.........................................nervous excitability

Cypripedium pubescens.........................wakefulness

Hyoscyamus niger.................................inability to fall asleep

Ignatia amara.........................................light sleep, worry

Passiflora incarnata................................restlessness, wakefulness

Pulsatilla................................................irregular sleep patterns

Valeriana officinalis................................tossing and turning

HPUS flower remedy

Aesculus hippocastanum, flos................calming


Indications And Usage

Uses: temporarily relieves symptoms due to occasional sleeplessness:

  • restlessness
  • nervousness
  • exhaustion
  • excitability
  • inability to fall or stay asleep
  • worry
  • as per various homeopathic Materia Medicas


Otc - Keep Out Of Reach Of Children

Warnings:

Keep out of reach of children.


Package Label.Principal Display Panel

King Bio Inc.

3 Westside Drive

Asheville, NC 28806

www.kingbio.com

Questions? Call 800.543.3245

Safe and Natural Homeopathic Spray


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