WATER
- Manufacturer
- Uriel Pharmacy, Inc
- Effective date
- 2024-12-02
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-06-01 02:29:14
Label at a glance#
ProductAvena sativa comp.
Active ingredientPASSIFLORA INCARNATA FLOWERING TOP, VALERIAN, COFFEA ARABICA SEED, ROASTED, AVENA SATIVA FLOWERING TOP, HOPS
Label structure9 sections
Contacts and useful links#
Label contents#
Full prescribing information#
INDICATIONS & USAGE SECTION
Directions: FOR ORAL USE ONLY.
DOSAGE & ADMINISTRATION SECTION
Take 3-4 times daily. Ages 12 and older: 10 drops.
Ages 2-11: 5 drops. Under age 2: Consult a doctor.
OTC - ACTIVE INGREDIENT SECTION
Active Ingredients: 100gm contains: 25gm Avena sativa (Oats) 1X, 1.2gm Humulus lupulus (Common Hop) 1X, 7.5gm Passiflora ex herba (Passionflower) 1X, 30gm Valeriana e rad Dec. (Valerian) 1X, Coffea tosta (Coffea seed) 60X
INACTIVE INGREDIENT SECTION
Inactive Ingredients: Distilled water, 45% Organic cane alcohol
Prepared using rhythmical processes.
OTC - PURPOSE SECTION
Use: Temporary relief of headache.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
KEEP OUT OF REACH OF CHILDREN.
WARNINGS SECTION
Warnings: Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated. Do not use if allergic to any ingredient. Consult a doctor before use for serious conditions or if conditions worsen or persist. If pregnant or nursing, consult a doctor before use. Do not use if safety seal is broken or missing.
OTC - QUESTIONS SECTION
Questions? Call 866.642.2858
Made with care by Uriel, East Troy, WI 53120
shopuriel.com Lot:
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 48951-1379-3 | Avena sativa comp. | 60 mL in 1 BOTTLE, DROPPER | LIQUID | 60 | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 48951-1379 | AVENA SATIVA COMP. LIQUID [URIEL PHARMACY, INC] | 1 | 1 package rows | 20241204_284f05dc-3cf8-dd09-e063-6394a90a43bf.zip |
Products#
Every source-derived product name is available through these pages.
- Avena sativa comp.
- WATER
- PASSIFLORA INCARNATA FLOWERING TOP
- VALERIAN
- COFFEA ARABICA SEED, ROASTED
- ALCOHOL
- AVENA SATIVA FLOWERING TOP
- HOPS
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 48951-1379 | 48951-1379-3 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| WATER | 059QF0KO0R | IACT |
| PASSIFLORA INCARNATA FLOWERING TOP | CLF5YFS11O | ACTIB |
| VALERIAN | JWF5YAW3QW | ACTIB |
| COFFEA ARABICA SEED, ROASTED | 9H58JRT35E | ACTIB |
| ALCOHOL | 3K9958V90M | IACT |
| AVENA SATIVA FLOWERING TOP | MA9CQJ3F7F | ACTIB |
| HOPS | 01G73H6H83 | ACTIB |
Source Document#
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 |
|---|---|---|---|---|---|---|
| 284f05dc-3cf9-dd09-e063-6394a90a43bf | 284f05dc-3cf8-dd09-e063-6394a90a43bf | 2024-12-02 | Warnings | 284f05dc-3cf9-dd09-e063-6394a90a43bf 284f05dc-3cf8-dd09-e063-6394a90a43bf |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.