Label: HYPERICUM PERFORATUM- hypericum perforatum 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 March 9, 2023

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

  • ACTIVE INGREDIENT

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

    Box - Hypericum perforatum 30C HPUS (**contains 0.443 mg of the active ingredient per pellet)

    Tube - (If using this product for toothache) Hypericum perforatum 30C HPUS (**contains 0.443 mg of the active ingredient per 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 nerve pain

  • INDICATIONS & USAGE

    Tube - Nerve pain*

    Box - temporarily relieves symptoms of nerve pain associated with minor injury such as: radiating or shooting pain, pain in the legs and back, toothaches*

    Tube - (If using this product for toothache) Relieves nerve pain*

  • WARNINGS

    Tube - (If using this product for toothache) For temporary use only until a dentist can be consulted.

  • 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, if new symptoms occur, or if redenss or swelling is present, as these could be signs of serious condition.

    Tube - (If using this product for toothache) Stop use and ask a doctor if symptoms persist for more than 3 days or worsen, if new symptoms occur, or if redenss or swelling is present, as these could be signs of serious condition.

  • PREGNANCY OR BREAST FEEDING

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

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

    Tube - (If using this product for toothache) If pregnant or breast-feeding, ask a health professional before use.

  • 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.

    Tube - (If using this product for toothache) 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

    On-the-Go Pain Relief*

    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

    Tube - (If using for product for toothache) - 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: 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.

    Tube - (If using this product for toothache) 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.

  • 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

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

  • PRINCIPAL DISPLAY PANEL

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  • INGREDIENTS AND APPEARANCE
    HYPERICUM PERFORATUM 
    hypericum perforatum pellet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0220-2581
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB) HYPERICUM PERFORATUM30 [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:0220-2581-4130 [hp_C] in 1 TUBE; Type 0: Not a Combination Product03/03/1983
    2NDC:0220-2581-433 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(0220-2581)