Active Ingredient(S)
Avena sativa 12X
Hepar sulphuris 12X
Pulsatilla 15X
Zincum valerianicum 12X
Sleeplessness Relief
FDA Label NDC 59262-601
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Similasan Corporation for the product Sleeplessness Relief (NDC 59262-601). 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(s), purpose, uses:, warnings:, keep out of reach of children, directions:, other information:, inactive ingredients:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
sleeplessness, nervousness
restlessness
irregular/agitated sleep
sleeplessness
Uses:
Relieves symptoms of occasional sleeplessness and/or restless sleep
- Difficulty in going to sleep and frequent waking during the night
- Disturbed sleep due to inability "to switch off", tenseness and restlessness
- Restless, light sleep and excessive dreaming
Warnings:
- Consult a physician before use if pregnant or breast feeding.
- Consult a physician if symptoms persist for more than 2 weeks or worsen.
- Keep this and all medications out of the reach of children.
- Do not use if tamper-evident seal is broken.
- In case of accidental overdose, get medical help or contact a Poison Control Center immediately.
Keep Out Of Reach Of Children
Keep this and all medications out of the reach of children
Directions:
For adults and children ages 2 and above:
- Remove tamper-evident seal from neck of bottle.
- Twist cap off bottle.
- Dispense 7-10 globules, place in mouth and allow to dissolve. Do not swallow globules.
- Allow the globules to dissolve in the mouth.
Occasional Sleeplessness: Take in the evening before going to bed. If you don't find relief immediately, repeat every fifteen minutes. Also take during the night if you wake frequently.
Other Information:
Active ingredients are microdiluted in accordance with the Homeopathic Pharmacopoeia of the United States, and are therefore non-toxic and have no known side effects.
Inactive Ingredients:
Calcium carbonate, Xylitol (Sugar-free)
Questions?
Call 1-800-240-9780 for 24hr recorded product information. Representatives available, M-F, 8am-5pm (MT), or visit: www.SimilasanUSA.com
Principal Display Panel
NDC 59262-601-30
Similasan
Sleeplessness Relief
Globules
15g/ 0.529 oz
Sleeplessness Relief Box (Sleeplessness Relief 1)
* Please review the disclaimer below.
