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  4. 61096-2001
  5. Label Information: Sleepease

FDA Label for Sleepease

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. WARNINGS
    3. OTC - KEEP OUT OF REACH OF CHILDREN
    4. INDICATIONS & USAGE
    5. DOSAGE & ADMINISTRATION
    6. OTHER SAFETY INFORMATION
    7. INACTIVE INGREDIENT
    8. OTC - PURPOSE
    9. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Sleepease Product Label

The following document was submitted to the FDA by the labeler of this product Eight & Company L.l.c. 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.

Otc - Active Ingredient



Active Ingredient: Aquilegia 4X, Avena 4X, Chamomilla 4X, Coffea cruda 200C, Cypripedium 4X, Humulus 4X, Kali phos 12X, Passiflora 4X, Valeriana 4X, Zinc met 12X.


Warnings



Warnings: If sleeplessness persists continuously for more than 2 weeks, consult your doctor. Insomnia may be a symptom of serious underlying medical illness. If pregnant or breast-feeding, ask a health care professional before use. Keep out of reach of children. Contains alcohol, in case of overdose, get medical help or contact a Poison Control Center right away.


Otc - Keep Out Of Reach Of Children



Keep out of reach of children.


Indications & Usage



Temporarily relieves the common symptoms of sleeplessness, including:

  • wakefulness
  • restlessness
  • emotional stress and anxiety
  • caffeine sensitivity

Dosage & Administration



Directions:

  • Adults and children over 12: 2 sprays into the mouth at bedtime and if sleep is interrupted.
  • Children Under 12: consult a health care professional.

Other Safety Information



Other Information: Do not use if the transparent seal around spray bottle is broken or missing.


Inactive Ingredient



Inactive Ingredients: Non-GMO Glycerin, organic alcohol 20% v/v, purified water.


Otc - Purpose



Temporarily relieves the common symptoms of sleeplessness, including:

° wakefulness

° restlessness

° emotional stress and anxiety

° caffeine sensitivity

° natural

° gluten free

° no artifical flavors or colors

° vegan

° no known negative side effects

° no known negative drug interactions


* Please review the disclaimer below.