FDA.reportPublic FDA data

Calm and Serenity

Manufacturer
Similasan Corporation
Effective date
2016-12-12
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:08:31

Label at a glance#

ProductCalm and Serenity
Active ingredientASAFETIDA, SELENICEREUS GRANDIFLORUS STEM, LYCOPUS VIRGINICUS, PASSIFLORA INCARNATA FLOWERING TOP
Label structure16 sections

Indications and 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

Dosage and administration

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.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Calm & Serenity

Drug Facts

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Asafoetida (Hing) 4X

Purpose

OTC - PURPOSE SECTION

apprehension, irritability, restlessness

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Cactus grandiflorus 4X

Purpose

OTC - PURPOSE SECTION

nervousness, restless sleep

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Lycopus virginicus (Sweet Bugle) 3X

Purpose

OTC - PURPOSE SECTION

inner tension, palpitations

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Passiflora (Passionflower) 4X

Purpose

OTC - PURPOSE SECTION

restless sleep from exhaustion

Uses*

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

• 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.

OTC - PREGNANCY OR BREAST FEEDING SECTION

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of accidental overdose get medical help, or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

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

OTHER SAFETY INFORMATION

Active ingredients are manufactured according to homeopathic principles.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Lactose, Magnesium stearate

Questions?

OTC - QUESTIONS SECTION

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

PACKAGE LABEL.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 TabletsPRINCIPAL DISPLAY PANEL NDC 59262-604-30 Calm & Serenity Asafoetida & Passionflower Actives 60 Dissolvable Tablets

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
59262-604-302021-01-29C16284748780-1ba0f9c33-1811-a910-e053-dadaa90a0b85Calm and Serenity

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59262-604-30Calm and Serenity60 in 1 BOTTLETABLET, ORALLY DISINTEGRATING601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59262-604CALM AND SERENITY (ASAFOETIDA, LYCOPUS VIRGINICUS, SELENICEREUS GRANDIFLORUS STEM AND PASSIFLORA INCARNATA FLOWERING TOP) TABLET, ORALLY DISINTEGRATING [SIMILASAN CORPORATION]1Legacy NDC, 1 package rows20170201_b81f8fcc-965b-42a8-8420-e34c6577c8b1.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59262-60459262-604-30

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
ASAFETIDAW9FZA51AS1ACTIB
SELENICEREUS GRANDIFLORUS STEM7114SV0MYKACTIB
LYCOPUS VIRGINICUSTWH5125Q6FACTIB
PASSIFLORA INCARNATA FLOWERING TOPCLF5YFS11OACTIB
LACTOSEJ2B2A4N98GIACT
MAGNESIUM STEARATE70097M6I30IACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
0626cdc4-764c-4f1f-aacd-04f933e0bd81b81f8fcc-965b-42a8-8420-e34c6577c8b12016-12-12WarningsExact identifier
spl id: 0626cdc4-764c-4f1f-aacd-04f933e0bd81
spl set id: b81f8fcc-965b-42a8-8420-e34c6577c8b1

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.