Active Ingredient
Menthol 5.4 mg
Cough Drops- Menthol Granule Lozenge
FDA Label NDC 87745-002
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Anhui Jiuhe Health Industry Co., Ltd for the product Cough Drops- Menthol Granule (NDC 87745-002). 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 active ingredient, purpose, use, warnings, do not use, when using, stop use, ask doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Cough suppressant / oral anesthetic
Use
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.
Do Not Use
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
When using this product do not exceed recommended dosage.
Stop Use
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; sore mouth symptoms do not improve in 7 days; irritation, pain, or redness persists or worsens.
Ask Doctor
Ask a doctor before use if you have chronic cough, asthma, emphysema, or excessive mucus.
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 one 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
Acacia, citric acid, corn starch, corn syrup, eucalyptus oil, FD&C blue 1, FD&C red 40, menthol flavor, pectin, potassium citrate, soy lecithin, sucralose, sucrose, water
Questions
Call +1-866-306-9136
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