FDA Label for Menthol Cough Suppressant Oral Anesthetic Cough Drops
View Indications, Usage & Precautions
Menthol Cough Suppressant Oral Anesthetic Cough Drops Product Label
The following document was submitted to the FDA by the labeler of this product Medical Group Care Llc. 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.
Drug Facts
Active Ingredient (In Each Lozenge)
Menthol 5.4 mg
Purposes
Cough suppressant/oral anesthetic
Uses
temporarily relieves:
• cough due to a cold • occasional minor irritation, pain, sore mouth, and sore throat
Warnings
Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting, consult a doctor promptly.
Ask a doctor before use if you have
• a persistent or chronic cough such as occurs with smoking, asthma, or emphysema
• cough accompanied by excessive phlegm (mucus)
When using this product do not exceed recommended dosage
Stop use and ask a doctor if
• cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition
• sore mouth symptoms do not improve in 7 days
• irritation, pain, or redness persists or worsens
Otc - Keep Out Of Reach Of Children
Keep this and all drugs out of the reach of children.
Directions
• adults and children 2 years and over: dissolve lozenge slowly in the mouth. Repeat every 2 hours as needed or as directed by a doctor
• children under 2 years of age: ask a doctor
Other Information
• store at room temperature.
• keep away from excessive heat or sunlight
• do not use if primary bag seal has been torn or broken.
• contains: SOY
Inactive Ingredients
citric acid, corn syrup, eucalyptus oil, FD&C blue 1, FD&C red 40, menthol flavor, potassium citrate, soy lecithin, sucralose, sucrose, water.
Questions Or Comments?
Call +1-866-306-9136
You may also report concerns to this phone number
Monday to Friday, 9 AM -5 PM Eastern Time or visit our website at www.mgc.us
Packaging
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