Sleep Well T012
Sleep Well T012 is an FDA drug label for the active ingredient ARSENICUM ALBUM, AVENA SATIVA, COFFEA CRUDA, KALI CARBONICUM, MAGNESIA CARBONICA, NUX VOMICA, PASSIFLORA INCARNATA, SEPIA, VALERIANA OFFICINALIS manufactured by Guangzhou Renuma Medical Systems Co., Ltd administered by ORAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20171024.
- Generic name
- ARSENICUM ALBUM, AVENA SATIVA, COFFEA CRUDA, KALI CARBONICUM, MAGNESIA CARBONICA, NUX VOMICA, PASSIFLORA INCARNATA, SEPIA, VALERIANA OFFICINALIS
- Manufacturer
- Guangzhou Renuma Medical Systems Co., Ltd
- Product type
- HUMAN OTC DRUG
- Route
- ORAL
- Dosage form
- N/A
- NDC
- 71742-0006
- Application
- N/A
- Label effective
- 20171024
Active ingredients
Indications & Usage
INDICATIONS: May temporarily relieve symptoms due to fatigue and restlessness from inability to sleep.
Dosage & Administration
DIRECTIONS: Adults and children 5 to 10 drops orally, 3 times daily or as otherwise directed by a health care professional. If symptoms persist, consult your health care professional. Consult a physician for use in children under 12 years of age.
Contraindications
Not available.
Warnings
WARNINGS: If pregnant or breast-feeding, ask a health care professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Do not use if tamper evident seal is broken or missing. Store in cool, dry place.
Adverse Reactions
Not available.