CALM AND SERENITY- asafoetida, lycopus virginicus, selenicereus grandiflorus stem and passiflora incarnata flowering top tablet, orally disintegrating 
Similasan Corporation

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

----------

Calm and Serenity

Calm & Serenity

Drug Facts

Active Ingredients

Asafoetida (Hing) 4X

Purpose

apprehension, irritability, restlessness

Active Ingredients

Cactus grandiflorus 4X

Purpose

nervousness, restless sleep

Active Ingredients

Lycopus virginicus (Sweet Bugle) 3X

Purpose

inner tension, palpitations

Active Ingredients

Passiflora (Passionflower) 4X

Purpose

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.

If pregnant, trying to get pregnant or breast feeding, ask a health professional before use.

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 getinfo@similasanusa.com.

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 PANEL
NDC 59262-604-30
Calm &
Serenity
Asafoetida &
Passionflower
Actives
60 Dissolvable Tablets

CALM AND SERENITY 
asafoetida, lycopus virginicus, selenicereus grandiflorus stem and passiflora incarnata flowering top tablet, orally disintegrating
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59262-604
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASAFETIDA (UNII: W9FZA51AS1) (ASAFETIDA - UNII:W9FZA51AS1) ASAFETIDA4 [hp_X]
SELENICEREUS GRANDIFLORUS STEM (UNII: 7114SV0MYK) (SELENICEREUS GRANDIFLORUS STEM - UNII:7114SV0MYK) SELENICEREUS GRANDIFLORUS STEM4 [hp_X]
LYCOPUS VIRGINICUS (UNII: TWH5125Q6F) (LYCOPUS VIRGINICUS - UNII:TWH5125Q6F) LYCOPUS VIRGINICUS3 [hp_X]
PASSIFLORA INCARNATA FLOWERING TOP (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA FLOWERING TOP - UNII:CLF5YFS11O) PASSIFLORA INCARNATA FLOWERING TOP4 [hp_X]
Inactive Ingredients
Ingredient NameStrength
LACTOSE (UNII: J2B2A4N98G)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
Product Characteristics
ColorWHITEScoreno score
ShapeROUNDSize8mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59262-604-3060 in 1 BOTTLE; Type 0: Not a Combination Product02/01/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED HOMEOPATHIC02/01/2017
Labeler - Similasan Corporation (111566530)

Revised: 12/2016
Document Id: 0626cdc4-764c-4f1f-aacd-04f933e0bd81
Set id: b81f8fcc-965b-42a8-8420-e34c6577c8b1
Version: 1
Effective Time: 20161212
 
Similasan Corporation