Label: COCCULUS INDICUS- anamirta cocculus seed 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 April 22, 2019

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

  • ACTIVE INGREDIENT

    Cocculus indicus 4X

    (**contains 0.443 mg of the active ingredient per pellet)

    Close
  • INDICATIONS & USAGE

    Motion sickness with a need to lie down*

    Close
  • STOP USE

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

    Close
  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding ask a health professional before use

    Close
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

    Close
  • SPL UNCLASSIFIED SECTION

    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.

    Close
  • INACTIVE INGREDIENT

    lactose, sucrose

    Close
  • DOSAGE & ADMINISTRATION

    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.

    Close
  • QUESTIONS

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

    Close
  • INGREDIENTS AND APPEARANCE
    COCCULUS INDICUS 
    anamirta cocculus seed pellet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0220-1458
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ANAMIRTA COCCULUS SEED (UNII: 810258W28U) (ANAMIRTA COCCULUS SEED - UNII:810258W28U) ANAMIRTA COCCULUS SEED 4 [hp_X]
    Inactive Ingredients
    Ingredient Name Strength
    SUCROSE (UNII: C151H8M554)  
    LACTOSE (UNII: J2B2A4N98G)  
    Product Characteristics
    Color white Score     
    Shape ROUND Size 4mm
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0220-1458-41 80 in 1 TUBE; Type 0: Not a Combination Product 03/03/1983
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved homeopathic 03/03/1983
    Labeler - Boiron (282560473)
    Registrant - Boiron Inc. (014892269)
    Establishment
    Name Address ID/FEI Business Operations
    Boiron 282560473 manufacture(0220-1458)
    Close