FDA.reportPublic FDA data

Calm and Collected

Manufacturer
Similasan Corporation
Effective date
2016-12-12
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:20:22

Label at a glance#

ProductCalm and Collected
Active ingredientPIPER METHYSTICUM ROOT
Label structure14 sections

Indications and uses

According to homeopathic principles, the active ingredients in this product temporarily relieve minor symptoms such as: • Nervousness • Restlessness

Dosage and administration

Take 1 tablet every 4 hours, up to 6 times a day. Do not swallow tablets whole, but chew or allow to dissolve in the mouth. Tablet may also be dissolved in a glass of water. Or use as directed by a licensed health care professional.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients      

OTC - ACTIVE INGREDIENT SECTION

Piper methysticum (Kava Kava Root) 12X

Purpose

OTC - PURPOSE SECTION

nervousness, restlessness

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Piper methysticum (Kava Kava Root) 15X

Purpose

OTC - PURPOSE SECTION

nervousness, restlessness

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Piper methysticum (Kava Kava Root) 30X

Purpose

OTC - PURPOSE SECTION

nervousness, restlessness

Uses*

INDICATIONS & USAGE SECTION

According to homeopathic principles, the active ingredients in this product temporarily relieve minor symptoms such as:
• Nervousness
• Restlessness

Warnings

WARNINGS SECTION

• According to homeopathic principles, symptoms may temporarily worsen before improving (Initial exacerbation of symptoms).

• Do not exceed recommended dosage.

• Not intended for children under 2.

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.

Stop use and ask a doctor if:

OTC - STOP USE SECTION

symptoms worsen or persist for more than 72 hours

Directions Adults and Children ages 2 and older:

DOSAGE & ADMINISTRATION SECTION

Take 1 tablet every 4 hours, up to 6 times a day. Do not swallow tablets whole, but chew or allow to dissolve in the mouth. Tablet may also be dissolved in a glass of water. Or use as directed by a licensed health care professional.

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 59262-606-30
Similasan
Calm &
Collected
Keva Keva
Actives
60 Dissolvable Tablets

PRINCIPAL DISPLAY PANEL NDC 59262-606-30 Similasan Calm & Collected Keva Keva Actives 60 Dissolvable TabletsPRINCIPAL DISPLAY PANEL NDC 59262-606-30 Similasan Calm & Collected Keva Keva Actives 60 Dissolvable Tablets

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
59262-606-302023-03-03C16284748780-1ba0f9c33-409e-a910-e053-dadaa90a0b85Calm and Collected
59262-606-302021-01-29C16284748780-1ba0f9c33-409e-a910-e053-dadaa90a0b85Calm and Collected

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59262-60659262-606-30

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
PIPER METHYSTICUM ROOTBOW48C81XPACTIB
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
5058819d-b3d8-4411-985b-b9623ad221f2b3c63baa-31f4-46d5-8d52-780623dd8f982023-03-02WarningsExact identifier
spl set id: b3c63baa-31f4-46d5-8d52-780623dd8f98

Reported adverse events (FAERS/openFDA)#

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