SEVENE USA - Deep Rest - Sleep problems

Manufacturer
SEVENE USA
Effective date
2026-08-13
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
daily-update
Hydrated at
2026-08-18 02:01:47

Label at a glance#

ProductDeep Rest Sleep problems
Active ingredientCRATAEGUS FRUIT, STRYCHNOS IGNATII SEED, COFFEA ARABICA SEED, ROASTED, TILIA CORDATA FLOWER, PASSIFLORA INCARNATA TOP, VALERIANA OFFICINALIS RHIZOME/ROOT
Label structure11 sections

Storage and handling

Store at 59-77°F.

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Coffea Cruda 9C - Crataegus 3C - Ignatia Amara 9C - Passiflora Incarnata (Classe N) 3C - Tilia Europaea 3C - Valeriana Officinalis 3C.

TRADITIONALLY USED FOR:

OTC - PURPOSE SECTION

This homeopathic medicine is made from a combination of ingredients traditionally used to relieve symptoms of sleep disturbances:

- Wakefulness

- Restlessnes

- Nervousness

- Irritability

DOSAGE & ADMINISTRATION SECTION

Adults/Children above 6 : spray 2 shots directly under the tongue 3 times a day until symptoms are relieved or as directed by a doctor.

INDICATIONS & USAGE SECTION

COFFEA CRUDA

Sleeplessness with Mental Hyperactivity .*

CRATAEGUS

Cardiac-related anxiety - Chest tension - Insomnia .*

IGNATIA AMARA

Sleeplessness, Nervousness, Hypersensitivity from Stress or Due to Emotional shock .*

PASSIFLORA INCARNATA

Restlessness - Sleeplessness .*

TILIA EUROPAEA

Nervous tension -Anxiety - Stress - Sleeplessness .*

VALERIANA OFFICINALIS

Nervousness - Anxiety - Restlessness - Insomnia - Hysterical states .*

WARNINGS SECTION

Consult a physician for use in children under 6 years of age.

Contact a doctor if symptoms persist.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

STORAGE AND HANDLING SECTION

Store at 59-77°F.

OTC - DO NOT USE SECTION

Do not use if seal is broken or missing.

INACTIVE INGREDIENT SECTION

Organic Alcohol 20%

Purified Water

QUESTIONS?

OTC - QUESTIONS SECTION

Distributed by Sevene USA

East Troy, WI 53120 USA

1-855 - OLLOMED

QUESTIONS? info@ollois.com

www.ollois.com

MADE IN FRANCE.

*Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated. No guarantee to be effective. A homeopathic dilution may not to be susceptible to scientific measurement. The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopeia of the United States.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

étiquette 15étiquette 15étuis 15étuis 15

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76472-701476472-7014-1, 76472-7014-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 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
Deep Rest Sleep problemsCOFFEA CRUDA 9C, CRATAEGUS 3C, IGNATIA AMARA 9C, PASSIFLORA INCARNATA 3C, TILIA EUROPAEA 3C, VALERIANA OFFICINALIS 3CSEVENE USA5510edcf-3a01-d8f0-e063-6294a90aced52026-08-13WarningsExact identifier
ndc (package): 76472-7014-2
ndc (package): 76472-7014-1
ndc (product): 76472-7014
ndc11 (package): 76472701402
ndc11 (package): 76472701401
spl id: 58eefa7c-41a4-ac1d-e063-6294a90ae627
spl set id: 5510edcf-3a01-d8f0-e063-6294a90aced5

Reported adverse events (FAERS/openFDA)#

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