FDA.reportPublic FDA data

Simvita

Manufacturer
RUBIMED AG
Effective date
2024-10-29
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:29:11

Label at a glance#

ProductSimvita
Active ingredientSUS SCROFA CEREBRUM, MATRICARIA CHAMOMILLA WHOLE, EPHEDRA DISTACHYA FLOWERING TWIG, CLAVICEPS PURPUREA SCLEROTIUM
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Drug Facts Active Ingredients: (HPUS*) 25% of each

Cerebrum 21X
Chamomilla 200C
Ephedra vulgaris 30X
Secale 12X

*The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States. †Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

INDICATIONS & USAGE SECTION

Uses: (†) Homeopathic remedy for feeling restless.

WARNINGS SECTION

Warnings:

Stop use if symptoms persist or worsen.

If you are pregnant or breastfeeding,consult a healthcare professional prior to use. 

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. 

DOSAGE & ADMINISTRATION SECTION

Directions: (adults & children 6 years & older)

Take 5 drops 3-6 times daily, or as

recommended by your health care

professional.

OTHER SAFETY INFORMATION

Other information: Store at 20 - 25°C

(68 - 77°F.) Do not use if box has been

tampered with, or if the safety seal of the

bottle is broken.

INACTIVE INGREDIENT SECTION

Inactive ingredients:Ethanol 20% USP,

Purified Water.

OTC - QUESTIONS SECTION

Manufactured by: OHM pharma, Inc, USA.

Distributed by: Privia Naturals, LLC.

9169 W State St #196

Garden City, ID 83714

www.privianaturals.com

Info@privianaturals.com Product of USA.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 66343-119-60

RUBIMED

Simvita

Homeopathic Medicine For

Feeling Restless

2.0 fl oz. 59mL 20% Ethanol

LabelLabel

CartonCarton

OTC - PURPOSE SECTION

Homeopathic Medicine For

Feeling Restless

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66343-119-60Simvita60 mL in 1 BOTTLELIQUID602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66343-119SIMVITA (CEREBRUM, CHAMOMILLA, EPHEDRA VULGARIS, SECALE) LIQUID [RUBIMED AG]2Current NDC, Legacy NDC, 1 package rows20241201_82331ea9-bd10-4f06-8c7c-d4ef47d585d6.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
66343-11966343-119-60

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MIACT
WATER059QF0KO0RIACT
SUS SCROFA CEREBRUM4GB5DQR532ACTIB
MATRICARIA CHAMOMILLA WHOLEG0R4UBI2ZZACTIB
EPHEDRA DISTACHYA FLOWERING TWIGR55VQ87DP3ACTIB
CLAVICEPS PURPUREA SCLEROTIUM01G9XEA93NACTIB

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
SimvitaCEREBRUM, CHAMOMILLA, EPHEDRA VULGARIS, SECALERUBIMED AG82331ea9-bd10-4f06-8c7c-d4ef47d585d62024-10-29WarningsExact identifier
ndc (package): 66343-119-60
ndc (product): 66343-119
ndc11 (package): 66343011960
spl id: 2817d2c8-bf23-c9b2-e063-6394a90a6d23
spl set id: 82331ea9-bd10-4f06-8c7c-d4ef47d585d6

Reported adverse events (FAERS/openFDA)#

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