Sleep Well

Manufacturer
Guangzhou Renuma Medical Systems Co., Ltd | Apotheca Company
Effective date
2017-10-24
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:08:55

Label at a glance#

ProductSleep Well T012
Active ingredientARSENIC TRIOXIDE, AVENA SATIVA FLOWERING TOP, ARABICA COFFEE BEAN, POTASSIUM CARBONATE, MAGNESIUM CARBONATE, STRYCHNOS NUX-VOMICA SEED, PASSIFLORA INCARNATA FLOWERING TOP, SEPIA OFFICINALIS JUICE, VALERIAN
Label structure9 sections

Dosage and administration

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.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

Arsenicum Album 30X, Avena Sativa 30X, Coffea Cruda 30X, Kali Carbonicum 30X, Magnesia Carbonica 30X, Nux Vomica 30X, Passiflora Incarnata 30X, Sepia 30X, Valeriana Officinalis 30X.

INDICATIONS:

OTC - PURPOSE SECTION

May temporarily relieve symptoms due to fatigue and restlessness from inability to sleep.

WARNINGS:

WARNINGS SECTION

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.

KEEP OUT OF REACH OF CHILDREN:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

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.

INDICATIONS:

INDICATIONS & USAGE SECTION

May temporarily relieve symptoms due to fatigue and restlessness from inability to sleep.

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

Demineralized water, Glycerin

QUESTIONS:

OTC - QUESTIONS SECTION

Distributed by:
Guangzhou Renuma Medical
Systems Co., Ltd.
No. 5, 2nd Floor, Ascendas 2nd Street
Sino-Singapore Guangzhou Knowledge City
Guangzhou 510555, China

PACKAGE LABEL DISPLAY:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SLEEP WELL
T012
HOMEOPATHIC
2 fl. oz. (59 ml)

Sleep WellSleep Well

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
63f39a63-5cd1-4016-bd86-2bbb0f6c3139Product name320240506
e5a77e9c-c528-733a-173d-914a234c024bProduct name520240506

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71742-0006-1Sleep WellT01259 mL in 1 BOTTLE, DROPPERLIQUID591

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71742-0006SLEEP WELL T012 (ARSENICUM ALBUM, AVENA SATIVA, COFFEA CRUDA, KALI CARBONICUM, MAGNESIA CARBONICA, NUX VOMICA, PASSIFLORA INCARNATA, SEPIA, VALERIANA OFFICINALIS) LIQUID [GUANGZHOU RENUMA MEDICAL SYSTEMS CO., LTD]1Current NDC, Legacy NDC, 1 package rows20171024_2dc9026a-b847-403b-a92e-5d629e4b3c68.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71742-000671742-0006-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Source Document#

Source XML

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sleep Well T012ARSENICUM ALBUM, AVENA SATIVA, COFFEA CRUDA, KALI CARBONICUM, MAGNESIA CARBONICA, NUX VOMICA, PASSIFLORA INCARNATA, SEPIA, VALERIANA OFFICINALISGuangzhou Renuma Medical Systems Co., Ltd2dc9026a-b847-403b-a92e-5d629e4b3c682017-10-24WarningsExact identifier
ndc (package): 71742-0006-1
ndc (product): 71742-0006
ndc11 (package): 71742000601
spl id: 76adb01c-5f32-4d49-abfc-adfbd560d699
spl set id: 2dc9026a-b847-403b-a92e-5d629e4b3c68

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.