Label: COLDCALM- onion, apis mellifera, eupatorium perfoliatum flowering top, gelsemium sempervirens root, potassium dichromate, strychnos nux-vomica seed, phytolacca americana root, pulsatilla vulgaris liquid
- NDC Code(s): 0220-9057-07, 0220-9057-09, 0220-9057-47
- 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 January 17, 2024
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 Ingredients
Active ingredients** (in each vial)
Allium cepa 3C HPUS (0.125 mL)
Apis mellifica 15C HPUS (0.125 mL)
Eupatorium perfoliatum 3C HPUS (0.125 mL)
Gelsemium sempervirens 6C HPUS (0.125 mL) (contains less than 10 -11 mg gelsemine alkaloids)
Kali bichromicum 6C HPUS (0.125 mL) (contains less than 10 -10 mg chromium)
Nux vomica 3C HPUS (0.125 mL) (contains less than 10 -5 mg strychnine alkaloids)
Phytolacca decandra 6C HPUS (0.125 mL)
Pulsatilla 6C HPUS (0.125 mL)
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 ... Relieves sneezing and runny nose
Apis mellifica 15C HPUS ... Relieves nasal congestion
Eupatorium perfoliatum 3C HPUS ... Relieves body aches 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 fits
Phytolacca decandra 6C HPUS ... Relieves mild fever
Pulsatilla 6C HPUS ... Relieves colds with a loss of taste and smell - INDICATIONS & USAGE
- WARNINGS
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Directions
Children 6 months of age and older:
Give 1 dose at the onset of symptoms. Repeat up to 6 times a day. Decrease frequency with improvement.
Children under 6 months of age:
Ask a doctor.
- Tear open the foil pouch at the notched edge.
- Snap off one pre-measured dose.
- Twist to open.
- Squeeze entire contents into mouth.
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SPL UNCLASSIFIED SECTION
do not use if glued carton flaps are open or if inner foil pouch and vials are not intact
do not refrigerate or freeze
after opening foil pouch: store unused vials in the foil pouch for no longer than 3 months
after opening the vial: the product must be used immediately
after administering discard vialdo not reuse
contains 0.0015% alcohol
Cold Relief*
Sneezing, Runny Nose, Nasal Congestion*
Calm symptoms Day or Night
Twist, Squeeze & Go
No Known Drug Interactions
40 Pre-measured liquid doses 0.34 fl oz (1 mL) per dose
30 Pre-measured liquid doses 0.34 fl oz (1 mL) per dose
5 Pre-measured liquid doses 0.34 fl oz (1 mL) per dose
*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
- Questions or comments?
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INGREDIENTS AND APPEARANCE
COLDCALM
onion, apis mellifera, eupatorium perfoliatum flowering top, gelsemium sempervirens root, potassium dichromate, strychnos nux-vomica seed, phytolacca americana root, pulsatilla vulgaris liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0220-9057 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ONION (UNII: 492225Q21H) (ONION - UNII:492225Q21H) ONION 3 [hp_C] APIS MELLIFERA (UNII: 7S82P3R43Z) (APIS MELLIFERA - UNII:7S82P3R43Z) APIS MELLIFERA 15 [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] POTASSIUM DICHROMATE (UNII: T4423S18FM) (DICHROMATE ION - UNII:9LKY4BFN2V) POTASSIUM DICHROMATE 6 [hp_C] STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919) STRYCHNOS NUX-VOMICA SEED 3 [hp_C] PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG) (PHYTOLACCA AMERICANA ROOT - UNII:11E6VI8VEG) PHYTOLACCA AMERICANA ROOT 6 [hp_C] PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV) PULSATILLA VULGARIS 6 [hp_C] Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALCOHOL (UNII: 3K9958V90M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0220-9057-07 1 in 1 PACKAGE 05/01/2017 1 5 in 1 POUCH; Type 0: Not a Combination Product 2 NDC:0220-9057-09 1 in 1 PACKAGE 05/01/2017 2 30 in 1 POUCH; Type 0: Not a Combination Product 3 NDC:0220-9057-47 1 in 1 PACKAGE 09/13/2023 3 40 in 1 POUCH; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 05/01/2017 Labeler - Laboratoires Boiron (282560473) Registrant - Boiron Inc. (014892269) Establishment Name Address ID/FEI Business Operations Boiron 282560473 manufacture(0220-9057) Establishment Name Address ID/FEI Business Operations Boiron 383674934 manufacture(0220-9057)
