FDA Label for Infant Cold
View Indications, Usage & Precautions
Infant Cold Product Label
The following document was submitted to the FDA by the labeler of this product Cvs Pharmacy. 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.
Active Ingredients Hpus
Euphrasia officinalis 6X
Eupatorium perfoliatum 6X
Gelsemium sempervirens 6X
Kali iodatum 6X
*The letters "HPUS" indicate that the components in this product are officially monographed in the Homoeopathic Pharmacopoeia of the United States.
Purpose
Euphrasia officinalis 6X..................................Runny eyes and nose
Eupatorium perfoliatum 6X.............................Sneezing, cough, headache
Gelsemium sempervirens 6X...........................Stuffy nose, sneezing
Kali iodatum 6X.............................................Runny eyes and nose, headache
Uses
Temporarily relieves the symptoms of runny nose, congestion and sneezing due to common head colds in children.*
*These claims have not been reviewed by the Food and Drug Administration. They are based on traditional homeopathic practice.
Warnings
Otc - Ask Doctor
As with any drug, ask a doctor before use if pregnant or nursing.
Stop use and ask a doctor if:
- symptoms persist for more than 72 hours or worsen
- if symptoms are accompanied by a high fever (over 101°F).
Otc - Keep Out Of Reach Of Children
Keep this and all medications out of the reach of children. In case of emergency or accidental overdose, contact a medical professional or a poison control center immediately.
Otc - Do Not Use
Do not use if security seal is broken or missing.
Directions
Children under 6 months of age: Consult a licensed health care professional before using this product.
Children 6 months to 1 year of age: Dissolve 2 tablets on the tongue every 15 minutes for 4 doses, then hourly until relieved, or as directed by a licensed health care professional.
Children 1 to 3 years of age: Dissolve 3 tablets on the tongue every 15 minutes for 4 doses, then hourly until relieved, or as directed by a licensed health care professional.
CVS/pharmacy Infant Cold Tablets are very soft and will dissolve almost instantly in the mouth.
Other Information
Store at room temperature (68-77°F)
Inactive Ingredients
Dextrose, maltodextrin, corn starch, crospovidone, magnesium stearate, lactose.
* Please review the disclaimer below.