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#
Contacts and useful links#
Label contents#
Full prescribing information#
Ingredients:
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:
Dextrose, Magnesium Stearate, Silica.
SPL UNCLASSIFIED SECTION
DISTRIBUTED BY: INDIANA BOTANIC GARDENS, INC.
3401 W. 37TH AVE. HOBART, IN 46342
Suggested Use:
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:
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.
Any Questions?
1-800-644-8327
website:
www.botanicchoice.com
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
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 10578-110-09 | 2021-01-08 | C162847 | 48780-1 | 9d75b9d0-ce95-f424-e053-dadaa90a57ce | Homeopathic Sleep |
| 10578-110-90 | 2021-01-08 | C162847 | 48780-1 | 9d75b9d0-ce95-f424-e053-dadaa90a57ce | Homeopathic Sleep |
| 10578-110-09 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-ce95-f424-e053-dadaa90a57ce | Homeopathic Sleep |
| 10578-110-90 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-ce95-f424-e053-dadaa90a57ce | Homeopathic Sleep |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| ARABICA COFFEE BEAN | ACTIVE INGREDIENT | 3SW678MX72 | 1 | |
| AVENA SATIVA FLOWERING TOP | ACTIVE INGREDIENT | MA9CQJ3F7F | 1 | |
| HOPS | ACTIVE INGREDIENT | 01G73H6H83 | 1 | |
| MATRICARIA RECUTITA | ACTIVE INGREDIENT | G0R4UBI2ZZ | 1 | |
| PASSIFLORA INCARNATA FLOWERING TOP | ACTIVE INGREDIENT | CLF5YFS11O | 1 | |
| STRYCHNOS IGNATII SEED | ACTIVE INGREDIENT | 1NM3M2487K | 1 | |
| ARABICA COFFEE BEAN | ACTIVE MOIETY | 3SW678MX72 | 1 | |
| AVENA SATIVA FLOWERING TOP | ACTIVE MOIETY | MA9CQJ3F7F | 1 | |
| HOPS | ACTIVE MOIETY | 01G73H6H83 | 1 | |
| MATRICARIA RECUTITA | ACTIVE MOIETY | G0R4UBI2ZZ | 1 | |
| PASSIFLORA INCARNATA FLOWERING TOP | ACTIVE MOIETY | CLF5YFS11O | 1 | |
| STRYCHNOS IGNATII SEED | ACTIVE MOIETY | 1NM3M2487K | 1 | |
| DEXTROSE | INACTIVE INGREDIENT | IY9XDZ35W2 | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | 1 |
Products#
Every source-derived product name is available through these pages.
- Homeopathic Sleep
- Oatstraw, Chamomile, Hops, Passion flower, Green coffee, Ignatius bean
- AVENA SATIVA FLOWERING TOP
- MATRICARIA RECUTITA
- HOPS
- PASSIFLORA INCARNATA FLOWERING TOP
- ARABICA COFFEE BEAN
- STRYCHNOS IGNATII SEED
- DEXTROSE
- MAGNESIUM STEARATE
- SILICON DIOXIDE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 10578-110 | 10578-110-90, 10578-110-09 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| AVENA SATIVA FLOWERING TOP | MA9CQJ3F7F | ACTIB |
| MATRICARIA RECUTITA | G0R4UBI2ZZ | ACTIB |
| HOPS | 01G73H6H83 | ACTIB |
| PASSIFLORA INCARNATA FLOWERING TOP | CLF5YFS11O | ACTIB |
| ARABICA COFFEE BEAN | 3SW678MX72 | ACTIB |
| STRYCHNOS IGNATII SEED | 1NM3M2487K | ACTIB |
| DEXTROSE | IY9XDZ35W2 | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
Source Document#
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.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, EXTENDED RELEASE / ORAL | 450 mg | ||
| DEXTROSE | DEXTROSE | IY9XDZ35W2 | TABLET, DELAYED RELEASE / ORAL | NA | ||
| DEXTROSE | DEXTROSE | IY9XDZ35W2 | PASTILLE / ORAL | 826 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | DROPS / ORAL | NA | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GEL / DENTAL | 19 %w/w | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, ORALLY DISINTEGRATING / ORAL | 68 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 69 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE / RESPIRATORY (INHALATION) | NA | ||
| DEXTROSE | DEXTROSE | IY9XDZ35W2 | POWDER, FOR SOLUTION / ORAL | NA | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | POWDER / ORAL | 602 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | SUSPENSION / ORAL | 64 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, FOR SUSPENSION / ORAL | 220 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | DROPS / ORAL | NA | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | POWDER, FOR SUSPENSION / ORAL | 2553 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET / BUCCAL | 17.5 mg | ||
| DEXTROSE | DEXTROSE | IY9XDZ35W2 | TABLET, EXTENDED RELEASE / ORAL | 103.95 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | PELLET / ORAL | 34 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, DELAYED RELEASE PARTICLES / ORAL | 170 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, CHEWABLE / ORAL | 254 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | POWDER / ORAL | 25 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET / ORAL | 750 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, FOR SUSPENSION / ORAL | 131 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | CREAM / TOPICAL | NA | ||
| DEXTROSE | DEXTROSE | IY9XDZ35W2 | TABLET, CHEWABLE / ORAL | 1286 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | WAFER / ORAL | 66 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 53 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, ORALLY DISINTEGRATING / ORAL | 187 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL | NA | ||
| DEXTROSE | DEXTROSE | IY9XDZ35W2 | INJECTION, SOLUTION / INTRAVENOUS | 51.7 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | IMPLANT / INTRAVITREAL | NA | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | IMPLANT / SUBCUTANEOUS | 0.5 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, COATED / ORAL | 184 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | LOZENGE / ORAL | 420 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | RING / VAGINAL | 2 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE, DELAYED RELEASE / ORAL | 40 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | INSERT / VAGINAL | 8 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, CHEWABLE / ORAL | 127 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, CHEWABLE, EXTENDED RELEASE / ORAL | 2 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | SUSPENSION, EXTENDED RELEASE / ORAL | 70 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | LOZENGE / TRANSMUCOSAL | 100 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, DELAYED RELEASE / ORAL | 144 mg | ||
| DEXTROSE | DEXTROSE | IY9XDZ35W2 | TABLET, COATED / ORAL | 132 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | LOZENGE / ORAL | 120 mg | ||
| DEXTROSE | DEXTROSE | IY9XDZ35W2 | SOLUTION / ORAL | 2489 mg/5ml | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE / ORAL | 300 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE, LIQUID FILLED / ORAL | 106 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GEL / TOPICAL | 6 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, FILM COATED / ORAL | 166 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TROCHE / ORAL | 315 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | FILM, SOLUBLE / ORAL | 2 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | INSERT / VAGINAL | 69 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | SYSTEM / TRANSDERMAL | 35 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | POWDER / TOPICAL | 104 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TAMPON / VAGINAL | NA | ||
| DEXTROSE | DEXTROSE | IY9XDZ35W2 | INJECTION / INTRAMUSCULAR | 5 %w/v | ||
| DEXTROSE | DEXTROSE | IY9XDZ35W2 | TROCHE / ORAL | 903.5 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, COATED / ORAL | 176 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GRANULE, FOR SUSPENSION / ORAL | 200 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE, EXTENDED RELEASE / ORAL | 168 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, FILM COATED / ORAL | 96 mg |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| a248e0e7-dfa5-4556-b256-48b420fc4d3f | 74ab0022-eb3a-4baf-8a4b-0623701deb3c | 2021-01-07 | Warnings | 74ab0022-eb3a-4baf-8a4b-0623701deb3c |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
