Label: CUPRUM METALLICUM- copper 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 January 20, 2023

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

  • ACTIVE INGREDIENT

    Active ingredient** (in each pellet)

    Cuprum metallicum 6C HPUS (0.44 mg)

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

  • PURPOSE

    Purpose*

    Cuprum metallicum 6C HPUS (0.44 mg) .... Relieves sudden and sharp pain associated with cramps and spasms

  • INDICATIONS & USAGE

    Uses*

    Tube - Sudden muscle cramps*

    Box - temporarily relieves pain associated with:

    • muscle cramps
    • muscle spasms
    • twitching
    • night cramps
  • 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, new symptoms occur, or if redness or swelling is present. These could be signs of a serious condition.

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breastfeeding, 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 overdose, get medical help or contact a Poison Control Center right away.

  • 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, and repeat 3 times a day until symptoms are relieved or as directed by a doctor. If pain occurs at night, take 5 pellets before bedtime.

    Children under 12 years of age: Ask a doctor.

  • INACTIVE INGREDIENT

    lactose, sucrose

  • SPL UNCLASSIFIED SECTION

    do not use if glued carton end flaps are open or if pellet dispenser seal is broken

    contains 0.25 g of sugar per dose

    3 TUBES

    APPROX. 80 PELLETS EACH

    TOTAL 240 PELLETS

    16 DOSES PER TUBE

    Nighttime Leg Cramp Relief*

    Muscle Cramps Spasms*

    Turn tube upside down. Twist until 5 pellets are dispensed. Remove cap and 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.

    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.


  • QUESTIONS

    1-800-BOIRON-1 (1-800-264-7661),
    BoironUSA.com Info@boiron.com

    Made in France
    Distributed by Boiron, Inc. Newtown Square, PA 19073

  • PRINCIPAL DISPLAY PANEL

    labellabel

  • INGREDIENTS AND APPEARANCE
    CUPRUM METALLICUM 
    copper pellet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0220-1623
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    COPPER (UNII: 789U1901C5) (COPPER - UNII:789U1901C5) COPPER6 [hp_C]  in 6 [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:0220-1623-416 [hp_C] in 1 TUBE; Type 0: Not a Combination Product03/03/1983
    2NDC:0220-1623-433 in 1 BOX06/07/2022
    26 [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(0220-1623)