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

  • NDC Code(s): 0220-9054-07, 0220-9054-08, 0220-9054-09, 0220-9054-10, view more
    0220-9054-46, 0220-9054-47
  • Packager: Laboratoires Boiron
  • 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 1, 2023

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  • ACTIVE INGREDIENT

    Active ingredients** (in each 1 mL vial)

    Chamomilla 9C HPUS (0.3mL)
    Phytolacca decandra 5C HPUS (0.3mL)
    Rheum 5C HPUS (0.3mL)

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

  • PURPOSE

    Purpose*

    Chamomilla 9C HPUS (0.3mL) ... Relieves teething pain accompanied by irritability
    Phytolacca decandra 5C HPUS (0.3mL) ... Relieves painful gums
    Rheum 5C HPUS (0.3mL) ... Relieves minor digestive disorders associated with teething

  • INDICATIONS & USAGE

    Uses*

    temporarily relieves symptoms of teething such as:

    • painful gums
    • irritability
    • minor digestive upsets associated with teething
  • WARNINGS

    Do not use if your child has a known allergy to any ingredient in this product.

  • STOP USE

    Stop use and ask doctor if symptoms persist for more than 3 days or worsen, or if swelling, fever, or rash develops.

  • KEEP OUT OF REACH OF CHILDREN

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

  • DOSAGE & ADMINISTRATION

    Children 1 month of age and older:

    Give 1 dose at the onset of symptoms.

    Wait 15 minutes, then repeat if needed for up to a total of 9 doses per day.

    Tear open the foil pouch at the notched edge.

    Snap off one pre-measured dose.

    Twist to open.

    Squeeze entire contents into mouth.

  • INACTIVE INGREDIENT

    alcohol, purified water

  • SPL UNCLASSIFIED SECTION

    do not use if glued carton end flaps are open or if inner foil pouch and vials are not intact

    do not refrigerate or freeze

    after opening foil pouch: store unused vials in the foil pouch for no longer than 3 months at a temperature that does not exceed 77° F (25° C)

    after opening the vial: the product must be used immediately

    after administering: discard vial

    do not reuse

    contains less than 0.001% alcohol

    Teething Relief*

    Painful Gums Irritability*

    *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.

  • HOW SUPPLIED

    Single-use liquid doses

    .034 fl oz each
    (1mL) each

  • QUESTIONS

    Questions, Comments?

    CamiliaTeething.com

    Boironusa.com

    Info@boironusa.com

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



    Distributed by Boiron Inc.

    Newtown Square, PA 19073-3267

    Made in France

  • PRINCIPAL DISPLAY PANEL

    labellabellabellabellabellabellabellabellabellabellabellabelLabellabelcamiliacamilia sample

  • 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)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0220-9054-461 in 1 PACKAGE01/01/2014
    110 in 1 POUCH; Type 0: Not a Combination Product
    2NDC:0220-9054-071 in 1 PACKAGE01/01/2014
    25 in 1 POUCH; Type 0: Not a Combination Product
    3NDC:0220-9054-10150 in 1 CARTON01/01/201402/27/2020
    35 in 1 POUCH; Type 0: Not a Combination Product
    4NDC:0220-9054-471 in 1 PACKAGE04/01/2020
    440 in 1 POUCH; Type 0: Not a Combination Product
    5NDC:0220-9054-081 in 1 PACKAGE12/01/2010
    515 in 1 POUCH; Type 0: Not a Combination Product
    6NDC:0220-9054-091 in 1 PACKAGE07/15/2011
    630 in 1 POUCH; Type 0: Not a Combination Product
    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)
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