Active Ingredient(S)
Menthol 5.8 mg
Exchange Select Cough Drop Lozenge
FDA Label NDC 83698-582
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 Exchange Select Cough Drop (NDC 83698-582). 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(s), purpose, use, 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
Purpose
Purposes cough suppressant, oral anesthetic
Use
temporary relieves: ■ cough due to 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 follow 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 a doctor if ■ cough persists for more than 1 week, tends to recur, or is accompained by fever, rash, or persistent headache. These could be signs of a serius 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.
Directions
■ adults and children 2 years and over: dissolve lozenge slowly in the mouth. Repeat every 2 hours as needed.
■ children under 2 years: ask a doctor.
Other Information
■ 5 calories per drop ■ 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
Acesulfame potassium, black cherry flavor, eucalyptus oil, FD&C blue 1, FD&C red 40, isomalt, maltitol, menthol flavor, soy lecithin, sucralose, water
Otc - Questions
call +8009352362. You may also report concerns to this phone number. Monday - Friday, 9 AM to 5 PM EASTERN TIME
* Please review the disclaimer below.
