Otc - Active Ingredient
Active ingredeint (in each Lozenge)
Menthol 5.4 mg
Menthol Flavor Cough Drop Lozenge
FDA Label NDC 83698-581
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Xiamen Kang Zhongyuan Biotechnology Co., Ltd. for the product Menthol Flavor Cough Drop (NDC 83698-581). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - ask doctor, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose
Cough suppressant/Oral anesthetic
Indications & Usage
Uses
temporarily relieves:
- cough due to a cold
- occasional minor irritation, pain, sore mouth, 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.
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 - When Using
When using this product do not exceed recommended dosage
Otc - Stop Use
Stop use and ask 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 does not improve in 7 days
- irritation, pain or redness persists or worsens
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Dosage & Administration
Directions
- adults and children 2 years and over: dissolve lozenge slowly in mouth. Repeat every 2 hours as needed or as directed by a doctor.
- children under 2 years: ask a doctor
Other Safety Information
Other information
- Store at room termperature
- keep away from excessive heat or sunlight
- do not use if primary bag seal has been torn or broken
- CONTAINS: SOY
Inactive Ingredient
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
Otc - Questions
Questions or comments?
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