Label: LEAFPRO CBDMED SOFTGELS FS QP 20- cannabidiol capsule, liquid filled

  • NDC Code(s): 73674-052-11, 73674-052-12
  • Packager: leafMed GmbH
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: CV

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated March 12, 2020

If you are a consumer or patient please visit this version.

  • Drug Facts

    Drug Facts

  • Active Ingredient (in each capsule)

    Cannabidiol 20mg

  • Purpose

    Anti-inflammatory, analgesic and sedative

  • Uses

    • pain relief
    • inflammation relief
    • soothing and relaxing effect
  • Warnings

    Allergy alert:

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

    Ask a doctor before use if

    you have

    • hepatopathy
    • depression
    • neural disease

    Possible side effects are

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

    Stop use and ask a doctor if

    you experience any side effects not listed on this carton.

    Ask a doctor or pharmacist before use if

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

    When using this product

    • 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,

    ask a health professional before use.

    Keep out of reach of children.

  • Directions

    • 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

    • 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:

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

  • Questions and comments:

    Phone: +1-212-5844230

    E-Mail: info@leafpharma-inc.com

  • Principal Display Panel - 30 Liquid filled capsules

    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_Label 30

  • Principal display panal - 60 Liquid filled capsules

    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 60

    Principal dispay panel - Label 60

  • INGREDIENTS AND APPEARANCE
    LEAFPRO CBDMED SOFTGELS FS QP 20 
    cannabidiol capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73674-052
    Route of AdministrationORALDEA ScheduleCV    
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CANNABIDIOL (UNII: 19GBJ60SN5) (CANNABIDIOL - UNII:19GBJ60SN5) CANNABIDIOL20 mg
    Inactive Ingredients
    Ingredient NameStrength
    HEMP (UNII: TD1MUT01Q7)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
    Product Characteristics
    Coloryellow (transparent yellow capsule with brown content) Scoreno score
    ShapeCAPSULESize15mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73674-052-111 in 1 CARTON04/01/2020
    130 in 1 JAR; Type 0: Not a Combination Product
    2NDC:73674-052-121 in 1 CARTON04/01/2020
    260 in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other04/01/2020
    Labeler - leafMed GmbH (342895093)
    Registrant - Leafpharma Inc. (117330180)
    Establishment
    NameAddressID/FEIBusiness Operations
    leafMed GmbH342895093pack(73674-052) , label(73674-052) , manufacture(73674-052)