FDA Label for Coldcalm Kids
View Indications, Usage & Precautions
Coldcalm Kids Product Label
The following document was submitted to the FDA by the labeler of this product Boiron. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
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)**
(in each vial)
The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.
Otc - 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 headeaches 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 mild fever*
Pulsatilla 6C HPUS (0.125 mL) ... Relieves colds with a loss of taste and smell*
Indications & Usage
Temporarily relieves cold symptoms such as sneezing, runny nose, and nasal congestion.
Otc - Ask Doctor
Ask a doctor before use in children under 6 months of age.
Otc - Stop Use
Stop use and ask doctor if sore throat, vomiting, skin rash, diarrhea, difficulty breathing, or fever above 100°F (38°C) develops, or if symptoms persist for more than 2 days, worsen or new symptoms occur.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away.
Dosage & Administration
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.
- Tear open the foil pouch at the notched edge.
- Snap off pre-measured dose.
- Twist to open.
- Squeeze entire contents into mouth.
Other
- 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 at a temperature that does not exceed 77°F (25°C)
- 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*
Inactive Ingredient
alcohol, purified water
Otc - Questions
ColdCalm.com
BoironUSA.com
[email protected]
1-800-BOIRON-1 (1-800-264-7661)
Distributed by Boiron Inc. Newtown Square, PA 19073-3267
* Please review the disclaimer below.