FDA Label for Sleep Relief

View Indications, Usage & Precautions

Sleep Relief Product Label

The following document was submitted to the FDA by the labeler of this product Homeostasis Laboratories, Inc.. 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 IngredientsPurpose
Arsenicum album 30C, HPUSRelieves anxiety and restlessness
Coffea cruda 30C, HPUSRelaxes the mind
Nitricum acidum 30C, HPUSRelieves frequent waking
Rhus toxicodendron 30C, HPUSRelieves restlessness
Selenium 30C, HPUSRelieves light sleeping
Zincum metallicum 30C, HPUSRelieves restlessness

"HPUS" indicates that the ingredient is officially included in the Homeopathic Pharmacopeia of the United States and the manufacturer has followed all guidelines set forth.

Statement of Identity: Nighttime sleep aid.


Uses



For the relief of sleeplessness and to reduce the difficulty of falling asleep.


Warnings



  • Do not use if outer package seal is broken.
  • If sleeplessness persists for more than 2 weeks or worsens, consult a doctor. Insomnia may be a symptom of a serious underlying illness.
  • Do not give to children under 12 years of age.

Otc - Pregnancy Or Breast Feeding



  • If pregnant or breast-feeding, consult a health professional before use.

Otc - Keep Out Of Reach Of Children



  • Keep out of reach of children.

Directions



(adults and children 12 years of age and older)

Before bedtime chew two tablets thoroughly, allowing each to dissolve in the mouth, then swallow.


Other Information



  • Safe to take with all other medications.
  • Store at 68-77°F (20-25°C) and keep out of direct sunlight.
  • Avoid humid or damp storage conditions. Close well when not in use.

Inactive Ingredients



Lactose, magnesium stearate (vegetable source), stevia leaf extract.


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