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

  • 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 20, 2023

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

  • ACTIVE INGREDIENT

    Active ingredients** (in each pellet)

    Allium cepa 3C HPUS (0.049 mg)

    Apis mellifica 6C HPUS (0.49 mg)

    Belladonna 6C HPUS (0.49 mg) (contains less than 10 -15 mg atropine alkaloids)

    Eupatorium perfoliatum 3C HPUS (0.49 mg)

    Gelsemium sempervirens 6C HPUS (0.49 mg)

    Kali birchromicum 6C HPUS

    Nux Vomica 3C HPUS (0.49 mg) (contains less than 10 -8 mg strychnine alkaloids)

    Phytolacca decandra 6C HPUS (0.49 mg)

    Pulsatilla 6C HPUS (0.49 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 (0.049 mg) ... Relieves Cold Symptoms: Sneezing, Runny Nose, Minor Sore Throat and Congestion

    Apis mellifica 6C HPUS (0.49 mg) ... Relieves Cold Symptoms: Sneezing, Runny Nose, Minor Sore Throat and Congestion

    Belladonna 6C HPUS (0.49 mg) ... Relieves Cold Symptoms: Sneezing, Runny Nose, Minor Sore Throat and Congestion

    Eupatorium perfoliatum 3C HPUS (0.49 mg) ... Relieves Cold Symptoms: Sneezing, Runny Nose, Minor Sore Throat and Congestion

    Gelsemium sempervirens 6C HPUS (0.49 mg) ... Relieves Cold Symptoms: Sneezing, Runny Nose, Minor Sore Throat and Congestion

    Kali birchromicum 6C HPUS ... Relieves Cold Symptoms: Sneezing, Runny Nose, Minor Sore Throat and Congestion

    Nux Vomica 3C HPUS (0.49 mg) ... Relieves Cold Symptoms: Sneezing, Runny Nose, Minor Sore Throat and Congestion

    Phytolacca decandra 6C HPUS (0.49 mg) ... Relieves Cold Symptoms: Sneezing, Runny Nose, Minor Sore Throat and Congestion

    Pulsatilla 6C HPUS (0.49 mg) ... Relieves Cold Symptoms: Sneezing, Runny Nose, Minor Sore Throat and Congestion

  • INDICATIONS & USAGE

    Uses*

    temporarily relieves cold symptoms such as:

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

    Warnings

  • ASK DOCTOR

    Ask a doctor before use if sore throat is severe, accompanied or followed by 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 symptoms occur.

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breastfeeding, 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 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.
  • SPL UNCLASSIFIED SECTION

    Other information

    • do not use if glued carton end flaps are open or if pellet dispenser seal is broken
    • contains 0.25 g of sugar per dose
  • INACTIVE INGREDIENT

    lactose, sucrose

  • QUESTIONS

    Questions or comments?

    1-800-264-7661

    Made in France

    Distributed by

    Boiron Inc.

    Newtown Square, PA

    19073

  • SPL UNCLASSIFIED SECTION

    2 PORTABLE TUBES

    APPROX. 80 PELLETS EACH

    TOTAL 160 PELLETS

    Multi-Symptom Cold Relief*

    No Known Drug Interactions

    Non-Drowsy

    *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

    label

    label

  • INGREDIENTS AND APPEARANCE
    COLDCALM 
    onion, apis mellifera, atropa belladonna, eupatorium perfoliatum flowering top, gelsemium sempervirens root, potassium dichromate, strychnos nux-vomica seed, phytolacca americana root, pulsatilla vulgaris whole pellet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0220-9098
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG) (PHYTOLACCA AMERICANA ROOT - UNII:11E6VI8VEG) PHYTOLACCA AMERICANA ROOT6 [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]
    ONION (UNII: 492225Q21H) (ONION - UNII:492225Q21H) ONION3 [hp_C]
    PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV) PULSATILLA VULGARIS6 [hp_C]
    POTASSIUM DICHROMATE (UNII: T4423S18FM) (DICHROMATE ION - UNII:9LKY4BFN2V) POTASSIUM DICHROMATE6 [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]
    STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919) STRYCHNOS NUX-VOMICA SEED3 [hp_C]
    Inactive Ingredients
    Ingredient NameStrength
    SUCROSE (UNII: C151H8M554)  
    LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)  
    Product Characteristics
    ColorwhiteScore    
    ShapeROUNDSize4mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0220-9098-422 in 1 BOX03/15/2022
    1NDC:0220-9098-4180 in 1 TUBE; Type 0: Not a Combination Product
    2NDC:0220-9098-4180 in 1 TUBE; Type 0: Not a Combination Product03/15/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic03/15/2022
    Labeler - Boiron (282560473)
    Registrant - Boiron, Inc. (014892269)
    Establishment
    NameAddressID/FEIBusiness Operations
    Boiron282560473manufacture(0220-9098)