Uses*: Homeopathic remedy to relieve occasional sleeplessness and restlessness in toddlers and children. *This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.
Directions: Use every night 5 minutes before bedtime until a regular sleep pattern is established. Repeat during the night every 15 minutes for up to 5 doses if necessary. Children 18 months to 3 years: 1 tablet. Children over 3 years: 2 tablets dissolved in mouth. Alternatively, crush and mix in warm water or soft food.
HPUS Active Ingredients: Equal volumes of each ingredient: Charmomilla 6C, Cina 30C, Cinchona 30C, Coffea cruda 6C, Nux vom 30C.
The letters HPUS indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.
Uses*: Homeopathic remedy to relieve occasional sleeplessness and restlessness in toddlers and children.
*This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.
Warnings: If symptoms persist or worsen, consult a healthcare professional. If pregnant or breastfeeding, ask a health professional before use. Keep this and all medication out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Directions: Use every night 5 minutes before bedtime until a regular sleep pattern is established. Repeat during the night every 15 minutes for up to 5 doses if necessary. Children 18 months to 3 years: 1 tablet. Children over 3 years: 2 tablets dissolved in mouth. Alternatively, crush and mix in warm water or soft food.
Contains no artificial flavors or colorants. No gluten added.
Tamper resistant for your protection. Use only if safety seals intact.
Inactive Ingredients: Acacia gum, distilled water, lactose, magnesium stearate, sucrose.
Keep this and all medication out of reach of children.
If pregnant or breastfeeding, ask a health professional before use.
Relieves occasional sleeplessness & restlessness in toddler and children.
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 68703-316-30 | 2023-03-06 | C162847 | 48780-1 | ba0f9c33-3b91-a910-e053-dadaa90a0b85 | NativeRemedies® Sleepy Jr.™ |
| 68703-316-30 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-3b91-a910-e053-dadaa90a0b85 | NativeRemedies® Sleepy Jr.™ |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68703-316-30 | Sleepy Jr | 180 in 1 BOTTLE, GLASS | TABLET | 180 | 3 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 68703-316 | 68703-316-30 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| STRYCHNOS NUX-VOMICA SEED | 269XH13919 | ACTIB |
| WATER | 059QF0KO0R | IACT |
| LACTOSE, UNSPECIFIED FORM | J2B2A4N98G | IACT |
| MATRICARIA CHAMOMILLA FLOWERING TOP OIL | SA8AR2W4ER | ACTIB |
| ACACIA | 5C5403N26O | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| ARTEMISIA CINA FLOWER | 28M1820ACT | ACTIB |
| COFFEA ARABICA FRUIT | HOX6BEK27Q | ACTIB |
| CINCHONA OFFICINALIS BARK | S003A158SB | ACTIB |
| SUCROSE | C151H8M554 | IACT |
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 |
|---|---|---|---|---|---|---|
| Sleepy Jr | CHAMOMILLA, CINA, CINCHONA, COFFEA CRUDA, NUX VOM | Silver Star Brands | 81a22c7c-69a5-ea2a-e053-2991aa0a1a5c | 2024-12-03 | Warnings | 68703-316-30 68703-316 68703031630 28687c5e-f464-d9eb-e063-6394a90a9427 81a22c7c-69a5-ea2a-e053-2991aa0a1a5c |
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