FDA Label for Cough And Cold Therapy For Kids
View Indications, Usage & Precautions
Cough And Cold Therapy For Kids Product Label
The following document was submitted to the FDA by the labeler of this product Everlaan Organics Inc. 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
Organic Camphor 4.7%
Organic Menthol 2.6%
Organic Eucalyptus Oil 1.2%
Purpose
Organic Camphor 4.7%......................Topical Antitussive
Organic Menthol 2.6%........................Topical Antitussive
Organic Eucalyptus Oil 1.2%..............Topical Antitussive
Uses
Temporarily relieves cough associated with the common cold.
Warnings
For external use only
Otc - Do Not Use
Do not use
- by mouth
- in nostrils
Otc - Ask Doctor
Ask a doctor before use if you have
- persistent or chronic cough such as occurs with asthma or if cough is accompanied by excessive phlegm (mucus).
Otc - When Using
When using this product, do not
- heat
- microwave
- add to hot water or any container where heating water. May cause splattering and result in burns.
Otc - Stop Use
Stop use and ask a doctor if
- a cough that persists for more than 1 week, tends to recur, or is accompanied by fevrer, rash, or persistent headache. A persistent cough may be a sign of a serious condition.
Otc - Keep Out Of Reach Of Children
Keep this and all drugs out of the reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.
Directions
See important warnings under "When using this product"
Children 2 years and older:
- rub on the throat and chest in a thick layer
- cover with a warm dry cloth if desired
- clothing should be loose about throat and chest to help vapors reach the nose and mouth
- use up to 3 times daily or as directed by a doctor
Children under 2 years of age: Ask a doctor.
Other Information
Tamper-evdent. Ensure seal is intact before use.
Inactive Ingredients
Organic Beeswax, Organic Coconut Oil, Organic Grapeseed Oil, Organic Jojoba Oil, Organic Kokum Butter, Organic Shea Butter, Vitamin E.
Package Label.Principal Display Panel
maple organics
Plant Based
Cough & Cold Therapy For Kids
Soothing & Calming Cough Suppressant
Net Wt. 2 oz / 56 g
* Please review the disclaimer below.