Label: COFFEA CRUDA- arabica coffee bean pellet

  • 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 June 5, 2023

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

  • ACTIVE INGREDIENT

    Tube - Coffea cruda 30C (**contains 0.443 mg of the active ingredient per pellet)

    Box - Coffea cruda 30C (**contains 0.443 mg of the active ingredient in each pellet)

    The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.

  • PURPOSE

    Box - Relieves sleeplessness with mental hyperactivity*

  • INDICATIONS & USAGE

    Tube - Sleeplessness with mental hyperactivity*

    Box - temporarily relieves occasional sleeplessness or restless sleep due to: mental hyperactivity, racing thoughts, obsessive thoughts, worries or concerns, helps to reduce difficulty falling asleep.*

  • WARNINGS

  • STOP USE

    Tube - Stop use and ask a doctor if symptoms persist for more than 3 days or worsen.

    Box - Stop use and ask a doctor if symptoms persist for more than 3 days or worsen. Insomnia may be a symptom of serious underlying illness.

  • PREGNANCY OR BREAST FEEDING

    Tube - Stop use and ask a doctor if symptoms persist for more than 3 days or worsen.

    Box - Stop use and ask a doctor if symptoms persist for more than 3 days or worsen. Insomnia may be a symptom of serious underlying illness.

  • KEEP OUT OF REACH OF CHILDREN

    Tube - Keep out of reach of children.

    Box - Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away.

  • SPL UNCLASSIFIED SECTION

    Tube - Do not use if pellet dispenser seal is broken.
    Contains approx 80 pellets.
    How to dispense pellets? Turn tube upside down. Twist until 5 pellets are dispensed into cap. Carefully remove the cap and use it to pour pellets under the tongue.
    *CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED.
    *C,K,CK, and X are homeopathic dilutions: see BoironUSA.com/info for details.

    Box - Do not use if glued carton end flaps are open or if pellet dispenser seal is broken.

    3 Tubes approx 80 pellets 16 Doses per tube Total 240 pellets

    How to dispense pellets? Turn tube upside down. Twist until 5 pellets are dispensed. Remove cap and pour pellets under the tongue.

    No known drug interactions

    No daytime drowsiness

    Meltaway Pellets
    *CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED.
    *C,K,CK, and X are homeopathic dilutions: see BoironUSA.com/info for details.

  • INACTIVE INGREDIENT

    Tube - lactose, sucrose

    Box - lactose, sucrose

  • DOSAGE & ADMINISTRATION

    Tube - Adults and children: At the onset of symptoms, dissolve 5 pellets under the tongue 3 times a day until symptoms are relieved or as directed by a doctor.

    Box - Adults and children 12 years of age and older: At the onset of symptoms, dissolve 5 pellets under the tongue 3 times a day until symptoms are relieved or as directed by a doctor. Children under 12 years of age: Ask a doctor.

  • QUESTIONS

    Tube - 1-800-BOIRON-1 (1-800-264-7661),
    BoironUSA.com Info@boiron.com
    Distributed by Boiron, Inc. Newtown Square, PA 19073

    Box - 1-800-BOIRON-1 (1-800-264-7661),
    BoironUSA.com Info@boiron.com
    Distributed by Boiron, Inc. Newtown Square, PA 19073

  • PRINCIPAL DISPLAY PANEL

    labellabel

  • INGREDIENTS AND APPEARANCE
    COFFEA CRUDA 
    arabica coffee bean pellet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0220-1444
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72) ARABICA COFFEE BEAN30 [hp_C]  in 30 [hp_C]
    Inactive Ingredients
    Ingredient NameStrength
    LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)  
    SUCROSE (UNII: C151H8M554)  
    Product Characteristics
    ColorwhiteScore    
    ShapeROUNDSize4mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0220-1444-4130 [hp_C] in 1 TUBE; Type 0: Not a Combination Product03/03/1983
    2NDC:0220-1444-433 in 1 BOX09/01/2020
    230 [hp_C] in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic03/03/1983
    Labeler - Boiron (282560473)
    Registrant - Boiron, Inc. (014892269)
    Establishment
    NameAddressID/FEIBusiness Operations
    Boiron282560473manufacture(0220-1444)