FDA.reportPublic FDA data

Sleep Assist

Manufacturer
The Magni Company | Apotheca Company
Effective date
2024-08-06
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:27:44

Label at a glance#

ProductSleep Assist
Active ingredientMATRICARIA CHAMOMILLA WHOLE, ARABICA COFFEE BEAN, AVENA SATIVA FLOWERING TOP, STRYCHNOS NUX-VOMICA SEED, PASSIFLORA INCARNATA FLOWERING TOP
Label structure10 sections

Indications and uses

Nighttime sleep aid

Dosage and administration

• Adults and children 12 years and above, dissolve 1 to 3 tablets under tongue 1/2 to 1 hour before bedtime. • Children under 12 years, consult a physician.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

Chamomilla 4X, Coffea Cruda 4X, Avena Sativa 6X, Nux Vomica 6X, Passiflora Incarnata 6X.

PURPOSE:

OTC - PURPOSE SECTION

Avena Sativa – For sleeplessness, Chamomilla – For irritability, sleeplessness, and restlessness, Coffea Cruda – For sleeplessness when the mind is awake, Nux Vomica- For those who awake early and cannot get back to sleep, Passiflora Incarnata – For restlessness due to exhaustion.

USES:

INDICATIONS & USAGE SECTION

Nighttime sleep aid

WARNINGS:

WARNINGS SECTION


• If pregnant or breastfeeding, ask a health professional before use.

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

KEEP OUT OF REACH OF CHILDREN:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

• Adults and children 12 years and above, dissolve 1 to 3 tablets under tongue 1/2 to 1 hour before bedtime.

• Children under 12 years, consult a physician.

OTHER INFORMATION:

OTHER SAFETY INFORMATION

Store tightly closed in a dry place

• Tamper sealed: Sealed for your protection. Do not use if seal is broken or missing

• The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopeia of the United

States

• These statements are supported by the traditional homeopathic principles

INACTIVE INGREDIENT SECTION

Lactose, Magnesium Stearate, Microcrystaline Cellulose.

QUESTIONS:

OTC - QUESTIONS SECTION

Dist. by:

The Magni Group, Inc.

McKinney, TX 75071 USA

www.magnilife.com

1-800-645-9199

PACKAGE LABEL DISPLAY:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MAGNILIFE®         HOMEOPATHIC 

SLEEP ASSIST       NDC 43689-0018-1

For sleeplessness and

difficulty falling asleep

125 Tablets

SLEEP ASSIST LBLSLEEP ASSIST LBL

SLEEP ASSIST CTNSLEEP ASSIST CTN

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43689-0018-1Sleep Assist125 in 1 BOTTLETABLET, ORALLY DISINTEGRATING1252
43689-0018-2Sleep Assist1 in 1 CARTONTABLET, ORALLY DISINTEGRATING12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43689-0018SLEEP ASSIST (CHAMOMILLA, COFFEA CRUDA, AVENA SATIVA, NUX VOMICA, PASSIFLORA INCARNATA) TABLET, ORALLY DISINTEGRATING [THE MAGNI COMPANY]2Current NDC, 2 package rows20240807_a7e428d3-9460-48d0-9c8d-1e8846bec857.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43689-001843689-0018-1, 43689-0018-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
MATRICARIA CHAMOMILLA WHOLEG0R4UBI2ZZACTIB
ARABICA COFFEE BEAN3SW678MX72ACTIB
AVENA SATIVA FLOWERING TOPMA9CQJ3F7FACTIB
STRYCHNOS NUX-VOMICA SEED269XH13919ACTIB
PASSIFLORA INCARNATA FLOWERING TOPCLF5YFS11OACTIB
LACTOSE MONOHYDRATEEWQ57Q8I5XIACT
MAGNESIUM STEARATE70097M6I30IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT

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 AssistCHAMOMILLA, COFFEA CRUDA, AVENA SATIVA, NUX VOMICA, PASSIFLORA INCARNATAThe Magni Companya7e428d3-9460-48d0-9c8d-1e8846bec8572024-08-06WarningsExact identifier
ndc (package): 43689-0018-1
ndc (package): 43689-0018-2
ndc (product): 43689-0018
ndc11 (package): 43689001801
ndc11 (package): 43689001802
spl id: 78240a31-a7d1-4474-86cb-bf32a9667488
spl set id: a7e428d3-9460-48d0-9c8d-1e8846bec857

Reported adverse events (FAERS/openFDA)#

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