Label: CAMILIA- matricaria recutita, rhubarb, phytolacca americana root liquid

  • 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 4, 2018

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

  • ACTIVE INGREDIENT

    Chamomilla 9C, Phytolacca decandra 5C, Rheum 5C

  • INDICATIONS & USAGE

    Temporarily relieves symptoms of teething, including painful gums and irritability.

    Helps relieve minor digestive disorders sometimes associated with teething.

  • DO NOT USE

    do not use if glued carton end flaps, inner foil pouch, and single-use container are not intact.

  • DOSAGE & ADMINISTRATION

    Children 1 month of age and older.
    Snap off one single-use dose.
    Twist cap to open.
    Squeeze entire contents into mouth.
    Repeat as needed, every 15 minutes, for 2 more doses.

  • INACTIVE INGREDIENT

    Purified water

  • HOW SUPPLIED

    Single-use liquid doses

    .034 fl oz each

  • PURPOSE

    Chamomilla 9C   Relieves teething pain accompanied by irritability
    Phytolacca decandra 5C Relieves painful gums
    Rheum 5C Relieves minor digestive disorders associated with teething

  • STORAGE AND HANDLING

    Store at 68-77 O F (20-25 O C)

  • QUESTIONS

    Questions, Comments?

    www.boironusa.com

    info@boironusa.com

    1-800-BOIRON-1 (1-800-264-7661)

    Boiron Information Center
    6 Campus Boulevard
    Newtown Square, PA 19073-3267

  • ASK DOCTOR


  • STOP USE

    Stop use and ask doctor if symptoms persist for more than 3 days or worsen of if inflammation, fever or rash develops. After administering, discard single-use container.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

  • PREGNANCY OR BREAST FEEDING


  • WHEN USING


  • WARNINGS


  • PRINCIPAL DISPLAY PANEL

    box

  • INGREDIENTS AND APPEARANCE
    CAMILIA 
    matricaria recutita, rhubarb, phytolacca americana root liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0220-9054
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA9 [hp_C]
    RHUBARB (UNII: G280W4MW6E) (RHUBARB - UNII:G280W4MW6E) RHUBARB5 [hp_C]
    PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG) (PHYTOLACCA AMERICANA ROOT - UNII:11E6VI8VEG) PHYTOLACCA AMERICANA ROOT5 [hp_C]
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0220-9054-0815 in 1 BOX; Type 0: Not a Combination Product12/01/2010
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic12/01/2010
    Labeler - Laboratoires Boiron (282560473)
    Registrant - Boiron Inc. (014892269)
    Establishment
    NameAddressID/FEIBusiness Operations
    Boiron383674934manufacture(0220-9054)