Label: COLICCOMFORT- activated charcoal, copper, citrullus colocynthis fruit 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 March 26, 2020

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  • ACTIVE INGREDIENT

    Carbo vegetabilis 5C HPUS

    Colocynthis 9C HPUS

    Cuprum metallicum 5C HPUS

  • INDICATIONS & USAGE

    Temporarily relieves symptoms associated with baby colic such as gas pain, irritability, stomach cramps, bloating, hiccups

  • DO NOT USE

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

    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

    Do not reuse

  • DOSAGE & ADMINISTRATION

    Children 1 month of age and older: Give 1 dose at the onset of symptoms, Wait 15 minutes, then repeate if needed for up to a total of 9 doses per day. For best results administer before meals.

    Tear open the foil pouch at the notched edge, Snap off one pre-measured dose, twist open, squeeze entire contents into mouth.

  • INACTIVE INGREDIENT

    alcohol, purified water

  • HOW SUPPLIED

    30 doses of 0.34 fl. oz. each

  • PURPOSE

    Carbo vegetabilis 5C HPUS .................relieves bloating associated with colic

    Colocynthis 9C HPUS .....................relieves cramping pains associated with colic

    Cuprum metallicum 5C HPUS ..........relieves abdominal cramps associated with colic

  • STORAGE AND HANDLING

    After opening the foil pack: store the unused doses in the foil pack at a temperature that does noe exceed 77 F (25 C)

    After opening the vial: the product must be used immediately

    After administrating: discal vial

  • QUESTIONS

    Questions or comments?

    BoironUSA.com

    Info@Boiron.com

    1-800-BOIRON-1

    (1-800-264-7661)

    Distributed by Boiron Inc.

  • ASK DOCTOR

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

  • WARNINGS

  • STOP USE

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

  • KEEP OUT OF REACH OF CHILDREN

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

  • PREGNANCY OR BREAST FEEDING

    NA

  • WHEN USING

    After administering, discard single use container.

    Do not reuse.

    After opening the single dose, the product must be used immediately. After administering, discard single use container. Do not reuse.

  • SPL UNCLASSIFIED SECTION

    contains 0.31% alcohol

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

    *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.

  • PRINCIPAL DISPLAY PANEL

    labelbox

  • INGREDIENTS AND APPEARANCE
    COLICCOMFORT 
    activated charcoal, copper, citrullus colocynthis fruit liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0220-9074
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACTIVATED CHARCOAL (UNII: 2P3VWU3H10) (ACTIVATED CHARCOAL - UNII:2P3VWU3H10) ACTIVATED CHARCOAL5 [hp_C]
    COPPER (UNII: 789U1901C5) (COPPER - UNII:789U1901C5) COPPER5 [hp_C]
    CITRULLUS COLOCYNTHIS FRUIT (UNII: 0E49E3V9U6) (CITRULLUS COLOCYNTHIS FRUIT - UNII:0E49E3V9U6) CITRULLUS COLOCYNTHIS FRUIT9 [hp_C]
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0220-9074-0930 in 1 BOX; Type 0: Not a Combination Product09/15/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic09/15/2018
    Labeler - Boiron (282560473)
    Registrant - Boiron (014892269)
    Establishment
    NameAddressID/FEIBusiness Operations
    Boiron383674934manufacture(0220-9074)
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