Label: PAIN RELIEF CAFFEINE AND HEMP (caffeine (coffeinum) 6x, hemp extract- cannabis sativa 2x liquid

  • NDC Code(s): 73002-351-01
  • Packager: Green Earth Health Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

Drug Label Information

Updated September 11, 2020

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

  • ACTIVE INGREDIENT

    Active Ingredients per dose:                                                                                                    Purpose
    Caffeine (Coffeinum) 6X (0.0027mg) HPUS                                                                                  Analgesic
    Hemp extract (Cannabis sativa) 2X (16.95 mg) HPUS                                                                   Anti-inflammatory
    Approximately 56 doses per container
    Reference: the Homeopathic Pharmacopoeia of the United States (HPUS)

  • PURPOSE

  • Indication:

    Temporarily relieves pain associated with sciatica, lower back pain and cystitis.

  • KEEP OUT OF REACH OF CHILDREN

  • Warnings:

    • Limit the use of caffeine-containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heart beat.
    • If symptoms persist or worsen, stop using this product and consult physician.
    • Avoid contact with eyes. If product gets into eyes, flush with water, seek medical attention.
    • If pregnant or breastfeeding or if diagnosed with psychiatric or mood disorder, seek medical advice before use.
    • Keep out of reach of children.
  • Directions For Use:

    • Do not use if tamperproof cover is missing.
    • Use graduated dropper and take 0.5ml of liquid.
    • Put the liquid directly in to the mouth or under the tongue.
    • Start using twice per day. Use as needed thereafter to relieve discomfort.
    • Allow several days for product to take maximum effect.
    • Use within 60 days of opening. Store at 50° to 75°F (10°C to 24°C).
  • Other Information:

    • Consult a medical professional if using other medications for known interactions.
    • Cannabidiol in hemp extract may alter the metabolism of other drugs.
  • Inactive Ingredients:

    Citric acid, flavoring, glycerin, potassium sorbate,purified water, sodium benzoate, vitamin C, xanthan gum

  • Product label

    image description

  • INGREDIENTS AND APPEARANCE
    PAIN RELIEF CAFFEINE AND HEMP 
    caffeine (coffeinum) 6x, hemp extract (cannabis sativa) 2x liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73002-351
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAFFEINE CITRATE (UNII: U26EO4675Q) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE CITRATE6 [hp_X]  in 1 mL
    CANNABIS SATIVA SUBSP. SATIVA FLOWERING TOP (UNII: 8X454SZ22D) (CANNABIS SATIVA SUBSP. SATIVA FLOWERING TOP - UNII:8X454SZ22D) CANNABIS SATIVA SUBSP. SATIVA FLOWERING TOP2 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SIRAITIA GROSVENORII FRUIT (UNII: NOU2FB51TW)  
    TEA LEAF (UNII: GH42T47V24)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73002-351-0128 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product09/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic09/01/2020
    Labeler - Green Earth Health Inc. (116983264)
    Registrant - Green Earth Health Inc. (116983264)
    Establishment
    NameAddressID/FEIBusiness Operations
    Maitland Labs of Central Florida080974960manufacture(73002-351)
    Establishment
    NameAddressID/FEIBusiness Operations
    Organics Corporation of America DBA Ambix Laboratories061061164manufacture(73002-351)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pure Source, LLC080354456manufacture(73002-351)