Freegells Cough Drops Menthol 30ct Lozenge
FDA Label NDC 83002-005

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by R.l. Albert & Son, Inc for the product Freegells Cough Drops Menthol 30ct (NDC 83002-005). 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, warning, keep out of reach of children, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Active Ingredient

→ Purpose

→ Use

→ Warning

→ Keep Out Of Reach Of Children

→ Directions

→ Other Information

→ Inactive Ingredients

→ Product Label

Active Ingredient

Menthol 5.4 mg

Purpose

Cough Suppressant / Oral anesthetic

Use

Temporarily relieves:

cough as may occur with a cold
occasional minor irritation and sore throat

Warning

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.

Ask a doctor before use if you have :

persistent or chronic cough such as occurs with smoking, asthma, or emphysema
cough accompanined by excessive phlegm (mucus)

stop use and ask 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

If pregnant or breast-feeding, ask a health professional before use.