Label: CHILDREN COLDCALM- onion, apis mellifera, atropa belladonna, eupatorium perfoliatum flowering top, gelsemium sempervirens root, potassium dichromate, strychnos nux-vomica seed, phytolacca americana root, pulsatilla vulgaris pellet
- NDC Code(s): 0220-9049-41, 0220-9049-42
- 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 27, 2023
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
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ACTIVE INGREDIENT
Allium cepa 3C HPUS (0.049.mg)**
Apis mellifica 6C HPUS (0.049mg)**
Belladonna 6C HPUS (0.049mg)** (contains less than 10 -15 mg atropine alkaloids.
Eupatorium perfoliatum 3C (0.049mg)**
Gelsemium sempervirens 6C (0.049mg)** (contains less an 10 -15 mg gelsemine alkaloids)Kali bichromicum 6C (0.049mg)** (contains less than 10 -13 mg chromium)
Nux vomica 3C (0.049mg)** (contains less than 10 -8 mg strychnine alkaloids)
Phytolacca decandra 6C (0.049mg)**
Pulsatilla 6C (0.049mg)**(in each pellet)
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
Allium cepa 3C HPUS (0.049.mg)* ... Relieves sneezing and runny nose
Apis mellifica 6C HPUS (0.049mg)* ... Relieves nasal congestion
Belladonna 6C HPUS (0.049mg)* ... Relieves colds with a sudden onset
Eupatorium perfoliatum 3C (0.049mg)* ... Relieves body aches associated with colds
Gelsemium sempervirens 6C (0.049mg)* ... Relieves body aches associated with coldsKali bichromicum 6C (0.049mg)* ... Relieves nasal discharge
Nux vomica 3C (0.049mg)* ... Relieves sneezing attacks
Phytolacca decandra 6C (0.049mg)* ... Relieves minor sore throat associated with colds
Pulsatilla 6C (0.049mg)* ... Relieves colds with a loss of taste and smell - INDICATIONS & USAGE
- INACTIVE INGREDIENT
- HOW SUPPLIED
- STORAGE AND HANDLING
- QUESTIONS
- ASK DOCTOR
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- WHEN USING
- DRUG INTERACTIONS
- WARNINGS
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DOSAGE & ADMINISTRATION
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.
Turn tube upside down, twist until 5 pellets are dispensed, remove cap and pour pellets under the tongue.
- PREGNANCY OR BREAST FEEDING
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
CHILDREN COLDCALM
onion, apis mellifera, atropa belladonna, eupatorium perfoliatum flowering top, gelsemium sempervirens root, potassium dichromate, strychnos nux-vomica seed, phytolacca americana root, pulsatilla vulgaris pelletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0220-9049 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 5 [hp_C] ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA 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] 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 SUCROSE (UNII: C151H8M554) LACTOSE (UNII: J2B2A4N98G) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0220-9049-42 1 in 1 BOX 09/08/2008 1 NDC:0220-9049-41 80 in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 09/08/2008 Labeler - Laboratoires Boiron (282560473) Registrant - Boiron Inc. (014892269) Establishment Name Address ID/FEI Business Operations Boiron 282560473 manufacture(0220-9049)