Sleep and Dream

Manufacturer
Similasan Corporation
Effective date
2016-12-12
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:08:30

Label at a glance#

ProductSleep and Dream
Active ingredientAVENA SATIVA FLOWERING TOP, CALCIUM SULFIDE, ANEMONE PULSATILLA, ZINC VALERATE DIHYDRATE
Label structure16 sections

Indications and uses

According to homeopathic principles, the active ingredients in this product temporarily relieve minor symptoms such as: • occasional sleeplessness and/or restless, light sleep • difficulty in going to sleep and frequent waking during the night • disturbed sleep due to inability “to switch off”, tenseness and restlessness

Dosage and administration

For adults and children ages 2 and above: Take 1-2 tablets 1 hour before bedtime and then again at bedtime or as needed. Tablet may also be dissolved in a glass of water.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Sleep & Dream

Drug Facts

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Avena sativa (Wild Oat) 12X

Purpose

OTC - PURPOSE SECTION

sleeplessness, nervousness

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Hepar sulphuris calcareum 12X

Purpose

OTC - PURPOSE SECTION

restlessness

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Pulsatilla (Pasque Flower) 15X

Purpose

OTC - PURPOSE SECTION

irregular or agitated sleep

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Zincum valerianicum 12X

Purpose

OTC - PURPOSE SECTION

sleeplessness

Uses*

INDICATIONS & USAGE SECTION

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

• occasional sleeplessness and/or restless, light sleep

• difficulty in going to sleep and frequent waking during the night

• disturbed sleep due to inability “to switch off”, tenseness and restlessness

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 2 and above:

Take 1-2 tablets 1 hour before bedtime and then again at bedtime or as needed. 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 59262-603-30
Sleep & Dream
Pasque Flower &
Wild Oat Actives
60 Dissolvable Tablets

PRINCIPAL DISPLAY PANEL NDC 59262-603-30 Sleep & Dream Pasque Flower & Wild Oat Actives 60 Dissolvable TabletsPRINCIPAL DISPLAY PANEL NDC 59262-603-30 Sleep & Dream Pasque Flower & Wild Oat Actives 60 Dissolvable Tablets

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
59262-303-302021-01-29C16284748780-1ba0f9c33-0d7e-a910-e053-dadaa90a0b85Sleep and Dream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59262-303-30Sleep and Dream60 in 1 BOTTLETABLET601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59262-303SLEEP AND DREAM (ANEMONE PULSATILLA, AVENA SATIVA FLOWERING TOP, CALCIUM SULFIDE AND ZINC VALERATE DIHYDRATE) TABLET [SIMILASAN CORPORATION]1Legacy NDC, 1 package rows20170201_05b23257-8a6e-46ae-90b1-b4b3cb104dfb.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59262-30359262-303-30

Ingredients#

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

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

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
63e8fc29-515f-4e8a-af82-7c0fdaac2a8b05b23257-8a6e-46ae-90b1-b4b3cb104dfb2016-12-12WarningsExact identifier
spl id: 63e8fc29-515f-4e8a-af82-7c0fdaac2a8b
spl set id: 05b23257-8a6e-46ae-90b1-b4b3cb104dfb

Reported adverse events (FAERS/openFDA)#

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