Label: COLDCALM KIDS- strychnos nux-vomica seed, pulsatilla vulgaris, onion, phytolacca americana root, potassium dichromate, gelsemium sempervirens root, eupatorium perfoliatum flowering top, apis mellifera, liquid
- NDC Code(s): 0220-9060-09
- 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 November 17, 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 1 mL 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 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 (0.125 mL) ... Relieves sneezing and runny nose
Apis mellifica 15C HPUS (0.125 mL) ... Relieves nasal congestion
Eupatorium perfoliatum 3C HPUS (0.125 mL) ... Relieves body aches associated with colds
Gelsemium sempervirens 6C HPUS (0.125 mL) ...Relieves headaches associated with colds
Kali bichromicum 6C HPUS (0.125 mL) ... Relieves nasal discharge
Nux vomica 3C HPUS (0.125 mL) ... Relieves sneezing attacks
Phytolacca decandra 6C HPUS (0.125 mL) ... Relieves occasional minor sore throat associated with colds
Pulsatilla 6C HPUS (0.125 mL) ... Relieves colds with a loss of taste and smell
- INDICATIONS & USAGE
- WARNINGS
- ASK DOCTOR
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
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DOSAGE & ADMINISTRATION
Children 4 years 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 4 years of age: Ask a doctor.
- Tear open the foil pouch at the notched edge.
- Snap off pre-measured dose.
- Twist to open.
- Squeeze entire contents into mouth.
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SPL UNCLASSIFIED SECTION
- do not use if glued carton end 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 vial
- do not reuse
- contains 0.0015% alcohol
30 Pre-Measured Liquid Doses
.034 fl oz (1 mL) per dose
No Known Drug Interactions
Multi-Symptom Cold Relief*
Cold Relief*
Sneezy, Runny Nose, Nasal Congestion*
- INACTIVE INGREDIENT
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
COLDCALM KIDS
strychnos nux-vomica seed, pulsatilla vulgaris, onion, phytolacca americana root, potassium dichromate, gelsemium sempervirens root, eupatorium perfoliatum flowering top, apis mellifera, liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0220-9060 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919) STRYCHNOS NUX-VOMICA SEED 3 [hp_C] PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV) PULSATILLA VULGARIS 6 [hp_C] 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] PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG) (PHYTOLACCA AMERICANA ROOT - UNII:11E6VI8VEG) PHYTOLACCA AMERICANA ROOT 6 [hp_C] Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0220-9060-09 30 in 1 PACKAGE 05/15/2018 1 5 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 05/15/2018 Labeler - Boiron (282560473) Registrant - Boiron Inc. (014892269) Establishment Name Address ID/FEI Business Operations Boiron 383674934 manufacture(0220-9060)
