FDA Label for Menthol Cough Drops
View Indications, Usage & Precautions
Menthol Cough Drops Product Label
The following document was submitted to the FDA by the labeler of this product Meijer. 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
Active ingredient (in each drop)
Menthol 5.4 mg
Otc - Purpose
Purpose
Cough suppressant / Oral anesthetic
Indications & Usage
Uses temporarily relieves:
cough as may occur with a cold
occasional minor irritation and sore throat
Warnings
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. If sore mouth symptoms do not improve in 7 days, see your dentist or doctor promptly. These symptoms may be serious.
Otc - Ask Doctor
Ask a doctor before use if you have:
persistent or chronic cough such as occurs with smoking, asthma, or emphysema
cough accompanied by excessive phlegm (mucus)
Otc - Stop Use
Stop use and consult doctor if
cough persists for more than 7 days, tends to recur, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.
sore throat is severe, or irritation, pain or redness lasts or worsens
sore mouth does not improve in 7 days
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a helth professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Dosage & Administration
DIrections
adults and children 5 years and over - dissolve 1 lozenge slowly in mouth. Repeat every 2 hours as needed or as directed by a doctor.
children under 5 years - ask a doctor
Other Safety Information
Other information
10 calories per drop
Inactive Ingredient
Inactive ingredients: corn starch, corn syrup, eucalyptus oil, FD&C blue no. 1, FD&C red no. 40, glycerin, gum arabic, medium chain triclycerides, natural flavor, potassium sorbate, soybean oil, sucrose and water.
Otc - Questions
Questions? Or to report an adverse event call 1-800-245-2898. Monday - Friday, 9AM to 4PM EST
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