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

Calm and Serenity by

Drug Labeling and Warnings

Calm and Serenity by is a Homeopathic medication manufactured, distributed, or labeled by Similasan Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59262-604
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ASAFETIDA (UNII: W9FZA51AS1) (ASAFETIDA - UNII:W9FZA51AS1)	ASAFETIDA	4 [hp_X]
SELENICEREUS GRANDIFLORUS STEM (UNII: 7114SV0MYK) (SELENICEREUS GRANDIFLORUS STEM - UNII:7114SV0MYK)	SELENICEREUS GRANDIFLORUS STEM	4 [hp_X]
LYCOPUS VIRGINICUS (UNII: TWH5125Q6F) (LYCOPUS VIRGINICUS - UNII:TWH5125Q6F)	LYCOPUS VIRGINICUS	3 [hp_X]
PASSIFLORA INCARNATA FLOWERING TOP (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA FLOWERING TOP - UNII:CLF5YFS11O)	PASSIFLORA INCARNATA FLOWERING TOP	4 [hp_X]

Inactive Ingredients
Ingredient Name	Strength
LACTOSE (UNII: J2B2A4N98G)
MAGNESIUM STEARATE (UNII: 70097M6I30)

Product Characteristics
Color	WHITE	Score	no score
Shape	ROUND	Size	8mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59262-604-30	60 in 1 BOTTLE; Type 0: Not a Combination Product	02/01/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED HOMEOPATHIC		02/01/2017

Labeler - Similasan Corporation (111566530)