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

  • NDC Code(s): 0220-9048-04, 0220-9048-29, 0220-9048-91
  • 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 23, 2024

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

  • ACTIVE INGREDIENT

    Active ingredients** (in each tablet)

    Allium cepa 3C HPUS (0.28 mg)

    Apis mellifica 6C HPUS (0.28 mg)

    Belladonna 6C HPUS (0.28 mg) (contains less than 10 -14 mg atropine alkaloids)

    Eupatorium perfoliatum 3C HPUS (0.28 mg)

    Gelsemium sempervirens 6C HPUS (0.28 mg) (contains less than 10 -14 gelsemine alkaloids)

    Kali bichromicum 6C HPUS (0.28 mg) (contains less than 10 -13 mg chromium)

    Nux vomica 3C HPUS (0.28 mg) (contains less than 10 -8 mg strychnine alkaloids)

    Phytolacca decandra 6C HPUS (0.28 mg)

    Pulsatilla 6C HPUS (0.28 mg)

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

  • PURPOSE

    Purpose*

    Allium cepa 3C HPUS ... Relieves sneezing and runny nose

    Apis mellifica 6C HPUS ... Relieves nasal congestion

    Belladonna 6C HPUS ... Relieves colds with a sudden onset

    Eupatorium perfoliatum 3C HPUS ... Relieves aches and pain associated with colds

    Gelsemium sempervirens 6C HPUS ... Relieves headaches associated with colds

    Kali bichromicum 6C HPUS ... Relieves nasal discharge

    Nux vomica 3C HPUS .... Relieves sneezing attacks

    Phytolacca decandra 6C HPUS ... Relieves occasional minor sore throat associated with colds

    Pulsatilla 6C HPUS ... Relieves colds with a loss of taste and smell

  • INDICATIONS & USAGE

    Uses*

    temporarily relieves cold symptoms such as:

    • sneezing
    • runny nose
    • nasal congestion
    • occasional minor sore throat
  • WARNINGS


  • ASK DOCTOR

    Ask a doctor before use

    • in children under 4 years of age
    • if sore throat is severe, accompanied or followed by fever, headache, rash, nausea, or vomiting.
  • STOP USE

    Stop use and ask a doctor if sore throat worsens or persists for more than 2 days

    nasal congestion worsens or lasts more than 5 days in children under 12 years of age or 7 days in adults

    new symptoms occur

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use.

  • 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

    Directions

    • Adults and children 6 years of age and older: At the onset of symptoms, dissolve 2 tablets in mouth every 15 minutes for 1 hour. Then, take 2 tablets every 6 hours. Decrease frequency with improvement.
    • Children 4 to under 6 years of age: Dissolve 2 tablets in 1 tablespoon of water for easier intake. Follow directions above.
  • SPL UNCLASSIFIED SECTION

    • do not use if glued carton end flaps are open or if the blister seal is broken
    • store below 86° F (30° C)

    Contains 20 meltaway tablets unflavored

    Contains 60 meltaway tablets unflavored

    Contains 120 meltaway tablets unflavored

    No Known Drug Interactions

    For Ages 4+ Years

    Non-Drowsy

    Cold Relief*

    Sneezing, Runny Nose, Minor Sore Throat*

    *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.

  • INACTIVE INGREDIENT

    Croscarmellose sodium, lactose, magnesium stearate

  • QUESTIONS

    Questions or comments

    ColdCalm.com

    BoironUSA.com

    Info@Boiron.com

    1-800-BOIRON-1

    (1-800-264-7661)

    Distributed by Boiron, Inc.

    Newtown Square, PA 19073

    Made in France

  • PRINCIPAL DISPLAY PANEL

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  • INGREDIENTS AND APPEARANCE
    COLDCALM 
    onion, apis mellifera, atropa belladonna, eupatorium perfoliatum flowering top, gelsemium sempervirens root, strychnos nux-vomica seed, phytolacca americana root, pulsatilla vulgaris, dichromate ion tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0220-9048
    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 MELLIFERA6 [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]
    DICHROMATE ION (UNII: 9LKY4BFN2V) (DICHROMATE ION - UNII:9LKY4BFN2V) DICHROMATE ION6 [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
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    LACTOSE (UNII: J2B2A4N98G)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUND (BOIRON) Size9mm
    FlavorImprint Code ;
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0220-9048-0460 in 1 BLISTER PACK; Type 0: Not a Combination Product01/01/1995
    2NDC:0220-9048-29120 in 1 BLISTER PACK; Type 0: Not a Combination Product12/09/2020
    3NDC:0220-9048-9120 in 1 BLISTER PACK; Type 0: Not a Combination Product07/14/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic01/01/1995
    Labeler - Laboratoires Boiron (282560473)
    Registrant - Boiron Inc. (014892269)
    Establishment
    NameAddressID/FEIBusiness Operations
    Boiron282560473manufacture(0220-9048)