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
- NDC Code(s): 0220-9098-41, 0220-9098-42
- Packager: 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 June 20, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
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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.
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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
- WARNINGS
- ASK DOCTOR
- STOP USE
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- SPL UNCLASSIFIED SECTION
- INACTIVE INGREDIENT
- QUESTIONS
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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
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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 pelletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0220-9098 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG) (PHYTOLACCA AMERICANA ROOT - UNII:11E6VI8VEG) PHYTOLACCA AMERICANA ROOT 6 [hp_C] APIS MELLIFERA (UNII: 7S82P3R43Z) (APIS MELLIFERA - UNII:7S82P3R43Z) APIS MELLIFERA 6 [hp_C] ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA 6 [hp_C] ONION (UNII: 492225Q21H) (ONION - UNII:492225Q21H) ONION 3 [hp_C] PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV) PULSATILLA VULGARIS 6 [hp_C] POTASSIUM DICHROMATE (UNII: T4423S18FM) (DICHROMATE ION - UNII:9LKY4BFN2V) POTASSIUM DICHROMATE 6 [hp_C] EUPATORIUM PERFOLIATUM FLOWERING TOP (UNII: 1W0775VX6E) (EUPATORIUM PERFOLIATUM FLOWERING TOP - UNII:1W0775VX6E) EUPATORIUM PERFOLIATUM FLOWERING TOP 3 [hp_C] GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q) GELSEMIUM SEMPERVIRENS ROOT 6 [hp_C] STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919) STRYCHNOS NUX-VOMICA SEED 3 [hp_C] Inactive Ingredients Ingredient Name Strength SUCROSE (UNII: C151H8M554) LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G) Product Characteristics Color white Score Shape ROUND Size 4mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0220-9098-42 2 in 1 BOX 03/15/2022 1 NDC:0220-9098-41 80 in 1 TUBE; Type 0: Not a Combination Product 2 NDC:0220-9098-41 80 in 1 TUBE; Type 0: Not a Combination Product 03/15/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 03/15/2022 Labeler - Boiron (282560473) Registrant - Boiron, Inc. (014892269) Establishment Name Address ID/FEI Business Operations Boiron 282560473 manufacture(0220-9098)