Relieves symptoms of occasional sleeplessness and/or restless sleep - Difficulty in going to sleep and frequent waking during the night - Disturbed sleep due to inability "to switch off", tenseness and restlessness - Restless, light sleep and excessive dreaming
For adults and children ages 2 and above: - Remove tamper-evident seal from neck of bottle. - Twist cap off bottle. - Dispense 7-10 globules, place in mouth and allow to dissolve. Do not swallow globules. - Allow the globules to dissolve in the mouth. Occasional Sleeplessness: Take in the evening before going to bed. If you don't find relief immediately, repeat every fifteen minutes. Also take during the night i...
www.SimilasanUSA.comAvena sativa 12X
sleeplessness, nervousness
Hepar sulphuris 12X
restlessness
Pulsatilla 15X
irregular/agitated sleep
Zincum valerianicum 12X
sleeplessness
Relieves symptoms of occasional sleeplessness and/or restless sleep
- Difficulty in going to sleep and frequent waking during the night
- Disturbed sleep due to inability "to switch off", tenseness and restlessness
- Restless, light sleep and excessive dreaming
- Consult a physician before use if pregnant or breast feeding.
- Consult a physician if symptoms persist for more than 2 weeks or worsen.
- Keep this and all medications out of the reach of children.
- Do not use if tamper-evident seal is broken.
- In case of accidental overdose, get medical help or contact a Poison Control Center immediately.
Keep this and all medications out of the reach of children
For adults and children ages 2 and above:
- Remove tamper-evident seal from neck of bottle.
- Twist cap off bottle.
- Dispense 7-10 globules, place in mouth and allow to dissolve. Do not swallow globules.
- Allow the globules to dissolve in the mouth.
Occasional Sleeplessness: Take in the evening before going to bed. If you don't find relief immediately, repeat every fifteen minutes. Also take during the night if you wake frequently.
Active ingredients are microdiluted in accordance with the Homeopathic Pharmacopoeia of the United States, and are therefore non-toxic and have no known side effects.
Calcium carbonate, Xylitol (Sugar-free)
Call 1-800-240-9780 for 24hr recorded product information. Representatives available, M-F, 8am-5pm (MT), or visit: www.SimilasanUSA.com
NDC 59262-601-30
Similasan
Sleeplessness Relief
Globules
15g/ 0.529 oz
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 59262-601-30 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-8464-f424-e053-dadaa90a57ce | Sleeplessness Relief |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 59262-601-30 | Sleeplessness Relief | 1078 in 1 BOTTLE, GLASS | GLOBULE | 1078 | 5 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 59262-601 | SLEEPLESSNESS RELIEF (AVENA SATIVA AND HEPAR SULPHURIS AND PULSATILLA AND ZINCUM VALERIANICUM) GLOBULE [SIMILASAN CORPORATION] | 5 | Legacy NDC, 1 package rows | 20130920_6b94321a-1a0a-4e6e-b931-618df8688eb2.zip |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 59262-601-30 | GM - Gram | 59262-601 | 5e082219-6906-49af-a314-ec29e4eb79b4 | 1 | 2016-06-14 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| ANEMONE PATENS | ACTIVE INGREDIENT | 4M1169RWJD | 5 | |
| AVENA SATIVA FLOWERING TOP | ACTIVE INGREDIENT | MA9CQJ3F7F | 5 | |
| CALCIUM SULFIDE | ACTIVE INGREDIENT | 1MBW07J51Q | 5 | |
| ZINC VALERATE DIHYDRATE | ACTIVE INGREDIENT | MN0RX54EQA | 5 | |
| ANEMONE PATENS | ACTIVE MOIETY | 4M1169RWJD | 5 | |
| AVENA SATIVA FLOWERING TOP | ACTIVE MOIETY | MA9CQJ3F7F | 5 | |
| CALCIUM SULFIDE | ACTIVE MOIETY | 1MBW07J51Q | 5 | |
| VALERIC ACID | ACTIVE MOIETY | GZK92PJM7B | 5 | |
| CALCIUM CARBONATE | INACTIVE INGREDIENT | H0G9379FGK | 5 | |
| XYLITOL | INACTIVE INGREDIENT | VCQ006KQ1E | 5 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 59262-601 | 59262-601-30 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| AVENA SATIVA FLOWERING TOP | MA9CQJ3F7F | ACTIB |
| CALCIUM SULFIDE | 1MBW07J51Q | ACTIB |
| ANEMONE PATENS | 4M1169RWJD | ACTIB |
| ZINC VALERATE DIHYDRATE | MN0RX54EQA | ACTIB |
| CALCIUM CARBONATE | H0G9379FGK | IACT |
| XYLITOL | VCQ006KQ1E | IACT |
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 |
|---|---|---|---|---|---|---|
| CALCIUM CARBONATE | CALCIUM CARBONATE | H0G9379FGK | GUM, CHEWING / BUCCAL | 3492 mg | ||
| CALCIUM CARBONATE | CALCIUM CARBONATE | H0G9379FGK | TABLET, DELAYED RELEASE / ORAL | 8.4 mg | ||
| XYLITOL | XYLITOL | VCQ006KQ1E | FILM, SOLUBLE / ORAL | 29 mg | ||
| XYLITOL | XYLITOL | VCQ006KQ1E | TABLET / ORAL | 15.04 mg | ||
| XYLITOL | XYLITOL | VCQ006KQ1E | SOLUTION / ORAL | 21600 mg | ||
| XYLITOL | XYLITOL | VCQ006KQ1E | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 72 mg | ||
| CALCIUM CARBONATE | CALCIUM CARBONATE | H0G9379FGK | TABLET, EXTENDED RELEASE / ORAL | 229.7 mg | ||
| CALCIUM CARBONATE | CALCIUM CARBONATE | H0G9379FGK | CAPSULE, DELAYED RELEASE / ORAL | 20 mg | ||
| XYLITOL | XYLITOL | VCQ006KQ1E | SUSPENSION, EXTENDED RELEASE / ORAL | 9000 mg | ||
| XYLITOL | XYLITOL | VCQ006KQ1E | PASTE / ORAL | 180 mg | ||
| CALCIUM CARBONATE | CALCIUM CARBONATE | H0G9379FGK | FILM, SOLUBLE / ORAL | 14 mg | ||
| CALCIUM CARBONATE | CALCIUM CARBONATE | H0G9379FGK | TABLET, FILM COATED / ORAL | 300 mg | ||
| CALCIUM CARBONATE | CALCIUM CARBONATE | H0G9379FGK | SOLUTION / AURICULAR (OTIC) | 0.38 %w/w | ||
| CALCIUM CARBONATE | CALCIUM CARBONATE | H0G9379FGK | CAPSULE, EXTENDED RELEASE / ORAL | 4 mg | ||
| XYLITOL | XYLITOL | VCQ006KQ1E | GUM, CHEWING / BUCCAL | 11915 mg | ||
| CALCIUM CARBONATE | CALCIUM CARBONATE | H0G9379FGK | TABLET, COATED / ORAL | 64.8 mg | ||
| XYLITOL | XYLITOL | VCQ006KQ1E | TABLET, ORALLY DISINTEGRATING / ORAL | 360 mg | ||
| XYLITOL | XYLITOL | VCQ006KQ1E | TABLET, EXTENDED RELEASE / ORAL | 2752 mg | ||
| CALCIUM CARBONATE | CALCIUM CARBONATE | H0G9379FGK | TABLET, CHEWABLE / ORAL | 1650 mg | ||
| XYLITOL | XYLITOL | VCQ006KQ1E | SPRAY / SUBLINGUAL | 22 mg | ||
| CALCIUM CARBONATE | CALCIUM CARBONATE | H0G9379FGK | TABLET / ORAL | 793 mg | ||
| CALCIUM CARBONATE | CALCIUM CARBONATE | H0G9379FGK | CAPSULE / ORAL | 349.9 mg | ||
| CALCIUM CARBONATE | CALCIUM CARBONATE | H0G9379FGK | SOLUTION / RESPIRATORY (INHALATION) | 4.02 %w/v | ||
| CALCIUM CARBONATE | CALCIUM CARBONATE | H0G9379FGK | POWDER, DENTIFRICE / DENTAL | 0.5 mg/mg | ||
| XYLITOL | XYLITOL | VCQ006KQ1E | SUSPENSION / ORAL | 1500 mg | ||
| CALCIUM CARBONATE | CALCIUM CARBONATE | H0G9379FGK | SOLUTION / INTRAVENOUS | 4.02 %w/v | ||
| XYLITOL | XYLITOL | VCQ006KQ1E | POWDER, FOR SUSPENSION / ORAL | 4223 mg |
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 |
|---|---|---|---|---|---|---|
| 088190e0-6a24-4b6c-a72a-00bd79ae7895 | 6b94321a-1a0a-4e6e-b931-618df8688eb2 | 2013-07-11 | Warnings | 088190e0-6a24-4b6c-a72a-00bd79ae7895 6b94321a-1a0a-4e6e-b931-618df8688eb2 |
Adverse event summaries are temporarily unavailable. Other product information remains available.