FDA.reportPublic FDA data

Combination Remedy 20 - Insomnia

Manufacturer
Warsan Homoeopathic Laboratories
Effective date
2017-12-25
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:09:05

Label at a glance#

ProductCombination Remedy 20 - Insomnia
Active ingredientSTRYCHNOS IGNATII SEED, PASSIFLORA INCARNATA FLOWERING TOP, ARABICA COFFEE BEAN, HYOSCYAMUS NIGER, VALERIAN
Label structure8 sections

Label contents#

Full prescribing information#

WARNINGS SECTION

Stop use and ask doctor if symptoms worsen or persist longer than 7 days.

If pregnant or breast-feeding, ask health professional before use.

Do not use if tamper evident seal is missing or broken.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

OTC - ACTIVE INGREDIENT SECTION

Coffea Cruda 1X

Hyoscyamus Niger 1X

Ignatia Amara 1X

Passiflora Incarnata 1X

Valeriana Officinalis 1x

OTC - PURPOSE SECTION

Temporary relief from difficulty sleeping, unrefreshing sleep, daytime drowsiness, nervous exhaustion.

INACTIVE INGREDIENT SECTION

Purified Water

Alcohol

DOSAGE & ADMINISTRATION SECTION

Adults and children 12 years and older: Take 10-15 drops in half cup of water 3 times a day.

Children 2 years to under 12 years: Take 8-10 drops in half cup of water of 3 times a day.

Children under 2 years: Consult doctor prior to use.

INDICATIONS & USAGE SECTION

Temporary relief from difficulty sleeping, unrefreshing sleep, daytime drowsiness, nervous exhaustion.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

insomnia combo 20 rev.jpginsomnia combo 20 rev.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69008-4070-12020-01-31C16284748780-19d75b9d0-c6e5-f424-e053-dadaa90a57ce5e576e66-1008-25a9-e053-2a91aa0a3d2e

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69008-4070-1Combination Remedy 20 - Insomnia20 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS202

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69008-4070COMBINATION REMEDY 20 - INSOMNIA (COFFEA CRUDA, HYOSCYAMUS NIGER, IGNATIA AMARA, PASSIFLORA INCARNATA, VALERIANA OFFICINALIS) SOLUTION/ DROPS [WARSAN HOMOEOPATHIC LABORATORIES]2Legacy NDC, 1 package rows20171226_5e576e66-1008-25a9-e053-2a91aa0a3d2e.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
69008-407069008-4070-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MIACT
WATER059QF0KO0RIACT
STRYCHNOS IGNATII SEED1NM3M2487KACTIB
PASSIFLORA INCARNATA FLOWERING TOPCLF5YFS11OACTIB
ARABICA COFFEE BEAN3SW678MX72ACTIB
HYOSCYAMUS NIGER4WRK2153H3ACTIB
VALERIANJWF5YAW3QWACTIB

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
612d2bd5-63bc-fcbc-e053-2a91aa0a61125e576e66-1008-25a9-e053-2a91aa0a3d2e2017-12-25WarningsExact identifier
spl id: 612d2bd5-63bc-fcbc-e053-2a91aa0a6112
spl set id: 5e576e66-1008-25a9-e053-2a91aa0a3d2e

Reported adverse events (FAERS/openFDA)#

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