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 Ingredients | Purpose |
Arsenicum album 30C, HPUS | Relieves anxiety and restlessness |
Coffea cruda 30C, HPUS | Relaxes the mind |
Nitricum acidum 30C, HPUS | Relieves frequent waking |
Rhus toxicodendron 30C, HPUS | Relieves restlessness |
Selenium 30C, HPUS | Relieves light sleeping |
Zincum metallicum 30C, HPUS | Relieves 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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