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

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: CV
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated March 19, 2020

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  • 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 (THC-free), 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

    T-FS QD

    20

    Cannabidiol

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

    30 Liquid filled capsules

    Principal display panel _ Carton 30

    Principal display panel _ Label 30

  • Principal display panal - 60 Liquid filled capsules

    leaf Pro

    CBDmed Softgel Capsules

    T-FS QD

    20

    Cannabidiol

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

    60 Liquid filled capsules

    Principal display panel _ Carton 60Principal display panel _ Label 60

  • INGREDIENTS AND APPEARANCE
    LEAFPRO CBDMED SOFTGELS T-FS QD 20 
    cannabidiol capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73674-061
    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:73674-061-111 in 1 CARTON04/01/2020
    130 in 1 JAR; Type 0: Not a Combination Product
    2NDC:73674-061-121 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(73674-061) , label(73674-061) , manufacture(73674-061)
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