Active Ingredients
Asafoetida (Hing) 4X
Cactus grandiflorus 4X
Lycopus virginicus (Sweet Bugle) 3X
Passiflora (Passionflower) 4X
Calm And Serenity
FDA Label NDC 59262-604
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 Calm And Serenity (NDC 59262-604). 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
apprehension, irritability, restlessness
nervousness, restless sleep
inner tension, palpitations
restless sleep from exhaustion
Uses*
According to homeopathic principles, the active ingredients in this product temporarily relieve minor symptoms such as:
• inner tension
• apprehension
• restlessness
• nervous sleeplessness, general irritability and tension
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 12 and above:
Dissolve 1 tablet in mouth every 15 minutes, up to 12 doses per day. 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 59262-604-30
Calm &
Serenity
Asafoetida &
Passionflower
Actives
60 Dissolvable Tablets
Principal Display Panelndc 59262-604-30calm &serenityasafoetida &passionfloweractives60 Dissolvable Tablets (Calm And Serenity 01)
* Please review the disclaimer below.
