FDA.reportPublic FDA data

Fragaria Vitis

Manufacturer
Uriel Pharmacy Inc.
Effective date
2021-06-04
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 22:43:59

Label at a glance#

ProductFragaria Vitis
Active ingredientFRAGARIA VESCA WHOLE, VITIS VINIFERA LEAF
Label structure9 sections

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

Directions: FOR ORAL USE ONLY.

DOSAGE & ADMINISTRATION SECTION

Take 3-4 times daily. Ages 12 and older: 1/8 teaspoon. Ages 2-11: 1/16 teaspoon. Under age 2: Consult a doctor.

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients: Fragaria vesca e fol. (Wild strawberry leaf) 1X double strength, Vitis vinifera e fol. (Grape vine leaf) 1X double strength

INACTIVE INGREDIENT SECTION

Inactive Ingredient: Lactose

OTC - PURPOSE SECTION

Use: Supports normal liver function.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN.

WARNINGS SECTION

Warnings: Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated. Do not use if allergic to any ingredient. Contains lactose. Consult a doctor before use for serious conditions or if conditions worsen or persist. If pregnant or nursing, consult a doctor before use. Do not use if safety seal is broken or missing.

OTC - QUESTIONS SECTION

Questions? Call 866.642.2858
Made by Uriel, East Troy, WI 53120
www.urielpharmacy.com Lot:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Fragaria Vitis PowderFragaria Vitis Powder

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
48951-416748951-4167-7

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
LACTOSE, UNSPECIFIED FORMJ2B2A4N98GIACT
FRAGARIA VESCA WHOLE5J340B7H82ACTIB
VITIS VINIFERA LEAFR1H893D80EACTIB

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
26cfe598-0edd-f0d6-e063-6394a90ad81ac3e1b459-ffa8-302e-e053-2995a90a72892024-11-13WarningsExact identifier
spl set id: c3e1b459-ffa8-302e-e053-2995a90a7289

Reported adverse events (FAERS/openFDA)#

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