Active Ingredient(S)
Menthol 5.4 mg
Exchange Select Cough Drops Lozenge
FDA Label NDC 55301-584
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Army & Air Force Exchange Service for the product Exchange Select Cough Drops (NDC 55301-584). 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 - stop use, otc - when using, 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 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, or 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 - 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 (a persistent cough may be a sign of a serious condition)
- sore mouth symptoms don’t improve in 7 days
- irritation, pain, or redness persists or worsens
Otc - When Using
When using this product:
Do not exceed recommended dosage.
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 mouth. Repeat every 2 hours as needed or as directed by a doctor.
- Children under 2 years: 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, acesulfame potassium, citric acid, corn starch, eucalyptus oil, FD&C blue 1, FD&C red 40, isomalt, maltitol, menthol flavor, pectin, potassium citrate, soy lecithin, sucralose, water
Otc - Questions
Call +8009352362
Available Monday–Friday, 9 AM–5 PM Eastern Time
Package Label - Principal Display Panel
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