Homeopathic Sleep

Manufacturer
Indiana Botanic Gardens | ASI Marketing Group
Effective date
2016-04-25
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 01:27:07

Label at a glance#

ProductHomeopathic Sleep
Active ingredientAVENA SATIVA FLOWERING TOP, MATRICARIA RECUTITA, HOPS, PASSIFLORA INCARNATA FLOWERING TOP, ARABICA COFFEE BEAN, STRYCHNOS IGNATII SEED
Label structure13 sections

Label contents#

Full prescribing information#

Ingredients:

OTC - ACTIVE INGREDIENT SECTION

Oatstraw ........................... 3X HPUS

Chamomile........................ 3X HPUS

Hops.................................. 3X HPUS

Passion flower .................. 3X HPUS

Green coffee ..................... 3C HPUS

Ignatius bean .................... 3C HPUS

SPL UNCLASSIFIED SECTION

The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Dextrose, Magnesium Stearate, Silica.

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY: INDIANA BOTANIC GARDENS, INC.

3401 W. 37TH AVE. HOBART, IN 46342

Suggested Use:

DOSAGE & ADMINISTRATION SECTION

Adults and children over 12 years, take 1-2 tablets, dissolve under tongue or chew 15-30 minutes before bedtime.

OTC - STOP USE SECTION

If symptoms persist for more than 7 days consult a health professional.

Warning:

WARNINGS SECTION

If you are taking any medications or are pregnant or breast feeding do not use prior to consulting a physician.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN.

SPL UNCLASSIFIED SECTION

For your protection, this container has an outer safety seal. (Do not accept if missing or broken.)

Best if used by date on bottle. Store in a dry cool place.

INDICATIONS & USAGE SECTION

For the relief of occasional sleeplessness and to help you sleep.

OTC - PURPOSE SECTION

For the relief of occasional sleeplessness and to help you sleep.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Homeopathic Sleep

For the relief of occasional sleeplessness and to help you sleep.

90 TABLETS

image of label
image of label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10578-110-092021-01-08C16284748780-19d75b9d0-ce95-f424-e053-dadaa90a57ceHomeopathic Sleep
10578-110-902021-01-08C16284748780-19d75b9d0-ce95-f424-e053-dadaa90a57ceHomeopathic Sleep
10578-110-092020-01-31C16284748780-19d75b9d0-ce95-f424-e053-dadaa90a57ceHomeopathic Sleep
10578-110-902020-01-31C16284748780-19d75b9d0-ce95-f424-e053-dadaa90a57ceHomeopathic Sleep

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ARABICA COFFEE BEANACTIVE INGREDIENT3SW678MX721
AVENA SATIVA FLOWERING TOPACTIVE INGREDIENTMA9CQJ3F7F1
HOPSACTIVE INGREDIENT01G73H6H831
MATRICARIA RECUTITAACTIVE INGREDIENTG0R4UBI2ZZ1
PASSIFLORA INCARNATA FLOWERING TOPACTIVE INGREDIENTCLF5YFS11O1
STRYCHNOS IGNATII SEEDACTIVE INGREDIENT1NM3M2487K1
ARABICA COFFEE BEANACTIVE MOIETY3SW678MX721
AVENA SATIVA FLOWERING TOPACTIVE MOIETYMA9CQJ3F7F1
HOPSACTIVE MOIETY01G73H6H831
MATRICARIA RECUTITAACTIVE MOIETYG0R4UBI2ZZ1
PASSIFLORA INCARNATA FLOWERING TOPACTIVE MOIETYCLF5YFS11O1
STRYCHNOS IGNATII SEEDACTIVE MOIETY1NM3M2487K1
DEXTROSEINACTIVE INGREDIENTIY9XDZ35W21
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I301
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU41

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10578-11010578-110-90, 10578-110-09

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 2 · 109 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, EXTENDED RELEASE / ORAL450 mgExact identifier — unii candidate
49 equally ranked IID candidates
DEXTROSEDEXTROSEIY9XDZ35W2TABLET, DELAYED RELEASE / ORALNAExact identifier — unii candidate
21 equally ranked IID candidates
DEXTROSEDEXTROSEIY9XDZ35W2PASTILLE / ORAL826 mgExact identifier — unii candidate
21 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30DROPS / ORALNAExact identifier — unii candidate
39 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4GEL / DENTAL19 %w/wExact identifier — unii candidate
49 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, ORALLY DISINTEGRATING / ORAL68 mgExact identifier — unii candidate
49 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL69 mgExact identifier — unii candidate
49 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4CAPSULE / RESPIRATORY (INHALATION)NAExact identifier — unii candidate
49 equally ranked IID candidates
DEXTROSEDEXTROSEIY9XDZ35W2POWDER, FOR SOLUTION / ORALNAExact identifier — unii candidate
21 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4POWDER / ORAL602 mgExact identifier — unii candidate
49 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30SUSPENSION / ORAL64 mgExact identifier — unii candidate
39 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, FOR SUSPENSION / ORAL220 mgExact identifier — unii candidate
49 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4DROPS / ORALNAExact identifier — unii candidate
49 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4POWDER, FOR SUSPENSION / ORAL2553 mgExact identifier — unii candidate
49 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET / BUCCAL17.5 mgExact identifier — unii candidate
39 equally ranked IID candidates
DEXTROSEDEXTROSEIY9XDZ35W2TABLET, EXTENDED RELEASE / ORAL103.95 mgExact identifier — unii candidate
21 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4PELLET / ORAL34 mgExact identifier — unii candidate
49 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, DELAYED RELEASE PARTICLES / ORAL170 mgExact identifier — unii candidate
49 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, CHEWABLE / ORAL254 mgExact identifier — unii candidate
49 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30POWDER / ORAL25 mgExact identifier — unii candidate
39 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET / ORAL750 mgExact identifier — unii candidate
49 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, FOR SUSPENSION / ORAL131 mgExact identifier — unii candidate
39 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30CREAM / TOPICALNAExact identifier — unii candidate
39 equally ranked IID candidates
DEXTROSEDEXTROSEIY9XDZ35W2TABLET, CHEWABLE / ORAL1286 mgExact identifier — unii candidate
21 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30WAFER / ORAL66 mgExact identifier — unii candidate
39 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, FILM COATED, EXTENDED RELEASE / ORAL53 mgExact identifier — unii candidate
39 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, ORALLY DISINTEGRATING / ORAL187 mgExact identifier — unii candidate
39 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
49 equally ranked IID candidates
DEXTROSEDEXTROSEIY9XDZ35W2INJECTION, SOLUTION / INTRAVENOUS51.7 mgExact identifier — unii candidate
21 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30IMPLANT / INTRAVITREALNAExact identifier — unii candidate
39 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30IMPLANT / SUBCUTANEOUS0.5 mgExact identifier — unii candidate
39 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, COATED / ORAL184 mgExact identifier — unii candidate
39 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30LOZENGE / ORAL420 mgExact identifier — unii candidate
39 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30RING / VAGINAL2 mgExact identifier — unii candidate
39 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4CAPSULE, DELAYED RELEASE / ORAL40 mgExact identifier — unii candidate
49 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4INSERT / VAGINAL8 mgExact identifier — unii candidate
49 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, CHEWABLE / ORAL127 mgExact identifier — unii candidate
39 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, CHEWABLE, EXTENDED RELEASE / ORAL2 mgExact identifier — unii candidate
49 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4SUSPENSION, EXTENDED RELEASE / ORAL70 mgExact identifier — unii candidate
49 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30LOZENGE / TRANSMUCOSAL100 mgExact identifier — unii candidate
39 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, DELAYED RELEASE / ORAL144 mgExact identifier — unii candidate
39 equally ranked IID candidates
DEXTROSEDEXTROSEIY9XDZ35W2TABLET, COATED / ORAL132 mgExact identifier — unii candidate
21 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4LOZENGE / ORAL120 mgExact identifier — unii candidate
49 equally ranked IID candidates
DEXTROSEDEXTROSEIY9XDZ35W2SOLUTION / ORAL2489 mg/5mlExact identifier — unii candidate
21 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4CAPSULE / ORAL300 mgExact identifier — unii candidate
49 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4CAPSULE, LIQUID FILLED / ORAL106 mgExact identifier — unii candidate
49 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4GEL / TOPICAL6 mgExact identifier — unii candidate
49 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, FILM COATED / ORAL166 mgExact identifier — unii candidate
49 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TROCHE / ORAL315 mgExact identifier — unii candidate
39 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4FILM, SOLUBLE / ORAL2 mgExact identifier — unii candidate
49 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30INSERT / VAGINAL69 mgExact identifier — unii candidate
39 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4SYSTEM / TRANSDERMAL35 mgExact identifier — unii candidate
49 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30POWDER / TOPICAL104 mgExact identifier — unii candidate
39 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TAMPON / VAGINALNAExact identifier — unii candidate
49 equally ranked IID candidates
DEXTROSEDEXTROSEIY9XDZ35W2INJECTION / INTRAMUSCULAR5 %w/vExact identifier — unii candidate
21 equally ranked IID candidates
DEXTROSEDEXTROSEIY9XDZ35W2TROCHE / ORAL903.5 mgExact identifier — unii candidate
21 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, COATED / ORAL176 mgExact identifier — unii candidate
49 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4GRANULE, FOR SUSPENSION / ORAL200 mgExact identifier — unii candidate
49 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4CAPSULE, EXTENDED RELEASE / ORAL168 mgExact identifier — unii candidate
49 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, FILM COATED / ORAL96 mgExact identifier — unii candidate
39 equally ranked IID candidates

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
a248e0e7-dfa5-4556-b256-48b420fc4d3f74ab0022-eb3a-4baf-8a4b-0623701deb3c2021-01-07WarningsExact identifier
spl set id: 74ab0022-eb3a-4baf-8a4b-0623701deb3c

Reported adverse events (FAERS/openFDA)#

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