FDA Label for Soothe And Sleep

View Indications, Usage & Precautions

Soothe And Sleep Product Label

The following document was submitted to the FDA by the labeler of this product Siddha Flower Essences Llc. 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.

Active Ingredient



Each dose contains equal parts of:

Aesculus hippocastanum, flos (White Chestnut) 5X HPUS

Chamomilla 6C HPUS

Ferr Phos 12X HPUS

Helianthemum nummularium, flos (Rock Rose) 5X HPUS

Mimulus guttatus, flos (Mimulus) 5X HPUS

Nat Mur 6X HPUS

Nat Phos 6X HPUS

Nat Sulph 6X HPUS

Phosphorus 6C HPUS

Verbena officinalis, flos (Vervain) 5X HPUS

Purpose



Each dose contains equal parts of:

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

Chamomilla 6C HPUS.............................................................restlessness, irritability; cries self to sleep

Ferr Phos 12X HPUS..............................................................restless, sleepless

Helianthemum nummularium, flos (Rock Rose) 5X HPUS...........nerves are weak; overreact and feel helpless

Mimulus guttatus, flos (Mimulus) 5X HPUS...............................anxieties cause inner tension

Nat Mur 6X HPUS...................................................................difficulty falling asleep; nightmares

Nat Phos 6X HPUS................................................................sleepless after excitement; sleepless from 12-3 am

Nat Sulph 6X HPUS................................................................uneasy sleep with anxious dream; tired in the morning

Phosphorus 6C HPUS.............................................................frequent waking; trouble going back to sleep; falls asleep late

Verbena officinalis, flos (Vervain) 5X HPUS...............................children are hyperactive and won't go to bed at night

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


Uses



  • temporarily relieves symptoms of
  • difficulty falling asleep
  • restlessness
  • sleepless after excitement
  • waking and trouble going back to sleep
  • nightmares


  • 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



  • Children 6 years and older 4 sprays in mouth at bedtime
  • for maximum effect 4 sprays 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

  • children 2 years to under 6 years

    2 sprays in mouth as needed

    children under 2 years
    consult a doctor
    • may also be applied externally to the top of the child's head

Other Information



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

Inactive Ingredients



Chamomile*, Chaparral*, Lemon Balm*, Licorice*, Mock Orange*, Natural Flavor, Purified Water, Valerian*


*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



flower essences and homeopathy:

  •    Jump start your child'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
  •    5 week supply


  • siddha kids

    stress relief
    attention and focus
    soothe and sleep
    temper tamer



Principal Display Panel



100% natural     -     no alcohol

siddha
cell salts + flower essences

kids 2+

soothe and sleep

Difficulty Falling Asleep
Restless and Sleepless
Anxious Dreams



sugar, dairy and gluten free

Homeopathic Remedy
1 US fl oz (29.6mL)




* Please review the disclaimer below.