FDA.reportPublic FDA data

leafPro CBDmed Softgel Capsules FS QP 20

Manufacturer
leafMed GmbH | Leafpharma Inc.
Effective date
2020-03-12
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:04:31

Label at a glance#

ProductleafPro CBDmed Softgels FS QP 20
Active ingredientCANNABIDIOL
Label structure11 sections

Indications and uses

pain relief inflammation relief soothing and relaxing effect

Dosage and administration

adults and children 12 years and over: take 1 – 3 capsules with a glass of water repeat procedure if required do not exceed the recommended daily dose of 400mg CBD (20 capsules) for full therapeutic effect use regularly for a period of at least 4-12 weeks

Label contents#

Full prescribing information#

Drug Facts

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient (in each capsule)

OTC - ACTIVE INGREDIENT SECTION

Cannabidiol 20mg

Purpose

OTC - PURPOSE SECTION

Anti-inflammatory, analgesic and sedative

Uses

INDICATIONS & USAGE SECTION

  • pain relief
  • inflammation relief
  • soothing and relaxing effect

Warnings

WARNINGS SECTION

Allergy alert:

SPL UNCLASSIFIED SECTION

do not use in case of hypersensitivity (allergy) to any of the ingredients.

Ask a doctor before use if

OTC - ASK DOCTOR SECTION

you have

  • hepatopathy
  • depression
  • neural disease

Possible side effects are

SPL UNCLASSIFIED SECTION

  • sleepiness
  • increase in liver enzymes
  • feeling very tired and weak

Stop use and ask a doctor if

OTC - STOP USE SECTION

you experience any side effects not listed on this carton.

Ask a doctor or pharmacist before use if

OTC - ASK DOCTOR/PHARMACIST SECTION

you are taking sleeping pills, tranquilizers, sedatives or other medicines.

When using this product

OTC - WHEN USING SECTION

  • avoid alcoholic drinks
  • alcohol, sleeping pills, tranquilizers and sedatives may increase drowsiness and may impair mental and/or physical abilities
  • be careful when driving a motor vehicle or operating machinery

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Directions

DOSAGE & ADMINISTRATION SECTION

  • adults and children 12 years and over: take 1 – 3 capsules with a glass of water
  • repeat procedure if required
  • do not exceed the recommended daily dose of 400mg CBD (20 capsules)
  • for full therapeutic effect use regularly for a period of at least 4-12 weeks

Other information

SPL UNCLASSIFIED SECTION

  • store at 15-25°C (59-77°F)
  • protect from excessive moisture
  • protect from direct sunlight
  • Desiccant bag inside – Do not eat.
  • TAMPER EVIDENT: do not use if inner mouth safety seal is broken or removed

Inactive ingredients:

INACTIVE INGREDIENT SECTION

Gelatin, full spectrum hemp extract, MCT coconut oil, silicon dioxide

Questions and comments:

OTC - QUESTIONS SECTION

Phone: +1-212-5844230

E-Mail: info@leafpharma-inc.com

Principal Display Panel - 30 Liquid filled capsules

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

leaf Pro

CBDmed Softgel Capsules

FS QP

20

Cannabidiol

Pain-relieving, anti-inflammatory, soothing and relaxing effect

30 Liquid filled capsules

Principal display panel_Carton 30Principal display panel_Carton 30Principal display panel_Label 30Principal display panel_Label 30

Principal display panal - 60 Liquid filled capsules

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

leaf Pro

CBDmed Softgel Capsules

FS QP

20

Cannabidiol

Pain-relieving, anti-inflammatory, soothing and relaxing effect

60 Liquid filled capsules

Principal display panel_ Label 60Principal display panel_ Label 60

Principal dispay panel - Label 60Principal dispay panel - Label 60

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
CANNABIDIOL Pharmacologic Class Indexing1Indexing - Pharmacologic Class20210608

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4d7a96d5-8256-4268-9a6c-25ea66d321feProduct name120180814

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73674-052-112022-01-28C16284748780-1d6a99b39-cf79-a426-e053-dadaa90af4c2leafPro CBDmed Softgel Capsules FS QP 20
73674-052-122022-01-28C16284748780-1d6a99b39-cf79-a426-e053-dadaa90af4c2leafPro CBDmed Softgel Capsules FS QP 20

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73674-052-11leafPro CBDmed Softgels FS QP 201 in 1 CARTONCAPSULE, LIQUID FILLED11
73674-052-11leafPro CBDmed Softgels FS QP 2030 in 1 JARCAPSULE, LIQUID FILLED301
73674-052-12leafPro CBDmed Softgels FS QP 2060 in 1 JARCAPSULE, LIQUID FILLED601
73674-052-12leafPro CBDmed Softgels FS QP 201 in 1 CARTONCAPSULE, LIQUID FILLED11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73674-052LEAFPRO CBDMED SOFTGELS FS QP 20 (CANNABIDIOL) CAPSULE, LIQUID FILLED [LEAFMED GMBH]1Legacy NDC, 4 package rows20200401_a0a9fdf2-53cd-53ee-e053-2995a90a8693.zip

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73674-05273674-052-11, 73674-052-12

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
HEMPTD1MUT01Q7IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
CANNABIDIOL19GBJ60SN5ACTIB
GELATIN, UNSPECIFIED2G86QN327LIACT

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
a0a9fdf2-53cc-53ee-e053-2995a90a8693a0a9fdf2-53cd-53ee-e053-2995a90a86932020-03-12WarningsExact identifier
spl id: a0a9fdf2-53cc-53ee-e053-2995a90a8693
spl set id: a0a9fdf2-53cd-53ee-e053-2995a90a8693

Reported adverse events (FAERS/openFDA)#

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