Active Ingredients
Avena sativa (Wild Oat) 12X
Hepar sulphuris calcareum 12X
Pulsatilla (Pasque Flower) 15X
Zincum valerianicum 12X
Sleep And Dream
FDA Label NDC 59262-303
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 Sleep And Dream (NDC 59262-303). 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 ingredients, 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 or agitated sleep
sleeplessness
Uses*
According to homeopathic principles, the active ingredients in this product temporarily relieve minor symptoms such as:
• occasional sleeplessness and/or restless, light sleep
• difficulty in going to sleep and frequent waking during the night
• disturbed sleep due to inability “to switch off”, tenseness and restlessness
Warnings
• According to homeopathic principles, symptoms may temporarily worsen before improving (Initial exacerbation of symptoms).
• Consult a physician if symptoms worsen or persist for more than 72 hours.
Keep Out Of Reach Of Children.
In case of accidental overdose get medical help, or contact a Poison Control Center right away.
Directions
For adults and children ages 2 and above:
Take 1-2 tablets 1 hour before bedtime and then again at bedtime or as needed. Tablet may also be dissolved in a glass of water.
Other Information
Active ingredients are manufactured according to homeopathic principles.
Inactive Ingredients
Lactose, Magnesium stearate
Questions?
Reach our representatives at 1-800-240-9780 or [email protected].
www.SimilasanUSA.com
*These statements are based upon traditional homeopathic principles. They have not been reviewed by the Food and Drug Administration.
Principal Display Panel
NDC 59262-603-30
Sleep & Dream
Pasque Flower &
Wild Oat Actives
60 Dissolvable Tablets
Principal Display Panelndc 59262-603-30sleep & Dreampasque Flower &wild Oat Actives60 Dissolvable Tablets (Sleep And Dream 01)
* Please review the disclaimer below.
