Label: CHILDREN COLDCALM- onion, apis mellifera, atropa belladonna, eupatorium perfoliatum flowering top, gelsemium sempervirens root, potassium dichromate, strychnos nux-vomica seed, phytolacca americana root, pulsatilla vulgaris pellet

  • NDC Code(s): 0220-9049-41, 0220-9049-42
  • 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 27, 2023

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  • ACTIVE INGREDIENT

    Allium cepa 3C HPUS (0.049.mg)**

    Apis mellifica 6C HPUS (0.049mg)**

    Belladonna 6C HPUS (0.049mg)** (contains less than 10 -15 mg atropine alkaloids.
    Eupatorium perfoliatum 3C (0.049mg)**
    Gelsemium sempervirens 6C (0.049mg)** (contains less an 10 -15 mg gelsemine alkaloids)

    Kali bichromicum 6C (0.049mg)** (contains less than 10 -13 mg chromium)
    Nux vomica 3C (0.049mg)** (contains less than 10 -8 mg strychnine alkaloids)
    Phytolacca decandra 6C (0.049mg)**
    Pulsatilla 6C (0.049mg)**

    (in each pellet)

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

  • PURPOSE

    Allium cepa 3C HPUS (0.049.mg)* ... Relieves sneezing and runny nose

    Apis mellifica 6C HPUS (0.049mg)* ... Relieves nasal congestion
    Belladonna 6C HPUS (0.049mg)* ... Relieves colds with a sudden onset
    Eupatorium perfoliatum 3C (0.049mg)* ... Relieves body aches associated with colds
    Gelsemium sempervirens 6C (0.049mg)* ... Relieves body aches associated with colds

    Kali bichromicum 6C (0.049mg)* ... Relieves nasal discharge
    Nux vomica 3C (0.049mg)* ... Relieves sneezing attacks
    Phytolacca decandra 6C (0.049mg)* ... Relieves minor sore throat associated with colds
    Pulsatilla 6C (0.049mg)* ... Relieves colds with a loss of taste and smell

  • INDICATIONS & USAGE

    Temporary relieves cold symptoms such as sneezing, runny nose, nasal congestion and minor sore throat.

  • INACTIVE INGREDIENT

    Lactose, Sucrose.

  • HOW SUPPLIED

    2 Tubes Approx. 80 pellets each, 3.8g (0.133 oz.) 16 doses per tube Total 160 Pellets

  • STORAGE AND HANDLING


  • QUESTIONS

    ColdCalm.com

    www.boironusa.com
    1-800-BOIRON-1

    Made in France

    Distributed by Boiron, Inc.
    Newtown Square, PA
    19073-3267

  • ASK DOCTOR


    Ask a doctor before use if sore throat is severe, accompanied or followed by a fever, headache, rash, nausea or vomiting.

  • STOP USE

    Stop use and ask a doctor if symptoms persist for more than 2 days or worsen, or if new symptom occur.

  • 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.

  • WHEN USING


  • DRUG INTERACTIONS


  • WARNINGS

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

  • DOSAGE & ADMINISTRATION

    Children 3 years of age and older: At the onset of symptoms, dissolve 5 pellets under the tongue every 15 minutes for 1 hour. Then, take 5 pellets every 6 hours. Decrease frequency with improvement.

    Children under 3 years of age: Ask a doctor.

    Turn tube upside down, twist until 5 pellets are dispensed, remove cap and pour pellets under the tongue.

  • PREGNANCY OR BREAST FEEDING


  • SPL UNCLASSIFIED SECTION

    *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

    labellabelboxtubetubebox

  • INGREDIENTS AND APPEARANCE
    CHILDREN COLDCALM 
    onion, apis mellifera, atropa belladonna, eupatorium perfoliatum flowering top, gelsemium sempervirens root, potassium dichromate, strychnos nux-vomica seed, phytolacca americana root, pulsatilla vulgaris pellet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0220-9049
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ONION (UNII: 492225Q21H) (ONION - UNII:492225Q21H) ONION3 [hp_C]
    APIS MELLIFERA (UNII: 7S82P3R43Z) (APIS MELLIFERA - UNII:7S82P3R43Z) APIS MELLIFERA5 [hp_C]
    ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA6 [hp_C]
    EUPATORIUM PERFOLIATUM FLOWERING TOP (UNII: 1W0775VX6E) (EUPATORIUM PERFOLIATUM FLOWERING TOP - UNII:1W0775VX6E) EUPATORIUM PERFOLIATUM FLOWERING TOP3 [hp_C]
    GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q) GELSEMIUM SEMPERVIRENS ROOT6 [hp_C]
    POTASSIUM DICHROMATE (UNII: T4423S18FM) (DICHROMATE ION - UNII:9LKY4BFN2V) POTASSIUM DICHROMATE6 [hp_C]
    STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919) STRYCHNOS NUX-VOMICA SEED3 [hp_C]
    PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG) (PHYTOLACCA AMERICANA ROOT - UNII:11E6VI8VEG) PHYTOLACCA AMERICANA ROOT6 [hp_C]
    PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV) PULSATILLA VULGARIS6 [hp_C]
    Inactive Ingredients
    Ingredient NameStrength
    SUCROSE (UNII: C151H8M554)  
    LACTOSE (UNII: J2B2A4N98G)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0220-9049-421 in 1 BOX09/08/2008
    1NDC:0220-9049-4180 in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic09/08/2008
    Labeler - Laboratoires Boiron (282560473)
    Registrant - Boiron Inc. (014892269)
    Establishment
    NameAddressID/FEIBusiness Operations
    Boiron282560473manufacture(0220-9049)
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