Sleep Spray
FDA Label NDC 69779-012

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Siddha Flower Essences Llc for the product Sleep (NDC 69779-012). 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 ingredient, purpose, uses, warnings, otc - pregnancy or breast feeding, otc - keep out of reach of children, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Active Ingredient

Each dose contains equal parts of:


Aesculus hippocastanum, flos (White Chestnut) 5X HPUS

Ferrum Phos 12X HPUS

Kali Carb 6C HPUS

Kali Phos 6X HPUS

Mag Phos 12X HPUS

Nat Mur 6X HPUS

Populus termula, flos (Aspen) 5X HPUS

Prunus cerasifera, flos 5X HPUS

Purpose

Each dose contains equal parts of:

Aesculus hippocastanum, flos (White Chestnut) 5X HPUS.........can't sleep because of thoughts going around in head

Ferrum Phos 12X HPUS..........................................................restlessness and sleeplessness; anxious dreams

Kali Carb 6C HPUS.................................................................agitated sleep; sleepless after 2 a.m.

Kali Phos 6X HPUS................................................................sleeplessness from excessive mental exertion; worry over business troubles; from nervous exhauston

Mag Phos 12X HPUS.............................................................sleep disturbed by troublesome dreams

Nat Mur 6X HPUS..................................................................drowsiness during day; difficulty falling asleep; agitated sleep

Populus termula, flos (Aspen) 5X HPUS...................................imagination runs wild

Prunus cerasifera, flos (Cherry Plum) 5X HPUS........................feeling blocked or congested inside

The letters HPUS indicate ingredients are in the Homeopathic Pharmacopoeia of the United States.

Uses

  • temporarily relieves symptoms of
  • occasional sleeplessness
  • agitated sleep
  • sleeplessness from mental exertion
  • drowsiness during day
  • anxious dreams
  • persistent unwanted thoughts

  • indications are based on homeopathic materia medica, not clinical tests.

Warnings

Stop use and ask a doctor if symptoms persist or worsen

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding ask a health professional before use

Otc - Keep Out Of Reach Of Children

Keep out of reach of children

Directions

  • spray in mouth at bedtime
  • for maximum effect spray in mouth one hour before bed and again at bedtime
  • can also be used after waking up in the middle of the night
  • use 5 days per week until symptoms are relieved

  • adults and children 12 years and over

    4-5 sprays per dose

    children 2 years to under 12 years

    2-3 sprays per dose

    children under 2 years
    consult a doctor

Other Information

  • do not use if plastic seal around cap is broken or missing.
  • store in a cool, dry place.

Inactive Ingredients

Dandelion*, German Chamomile*, Licorice*, Lotus*, Natural Flavor, Purified Water, Sandalwood*, Valerian*, Ylang Ylang*


*flower essence

Description

Questions or Comments?

Call 800.570.0021

Between 9am-5pm PST

[email protected]

siddhaflowers.com


MFD by Siddha Flower Essences
Oxnard, CA 93030



Made in USA

Side Panel

homeopathy and flower essences:

  •    Jump start your body's natural ability to heal
  •    Natural, safe and non-habit forming
  •    No contraindications.  May be effectively used with drugs and other supplements
  •    Alcohol, sugar, dairy and gluten free
  • Prepared in purified water with natural preservatives
  •    Blends time-tested natural medicine with modern technology
  •    One month supply


  • FOUNDATIONAL REMEDIES
    may be used with targeted remedies

    stress relief
    daily alignment

    emotional detox
    deep-seated stress



    TARGETED REMEDIES

    sleep                                    male virility
    healthy hair                           blood sugar
    female balance                      lung and sinus
    muscles and joints                 throat and voice
    youthful skin                          teeth and gums
    happy heart                           hearing
    digestion                               sight

Principal Display Panel

100% natural     -     no alcohol

siddha
cell salts + flower essences

sleep

Difficulty Falling Asleep
Restless and Sleepless
Agitated Sleep



sugar, dairy and gluten free

Homeopathic Remedy
1 US fl oz (29.6mL)


Sleep Carton (Sleepcarton)

Sleep Carton (Sleepcarton)

* Please review the disclaimer below.