Freegells Cough Drops Menthol Honey Lemon Lozenge
FDA Label NDC 71165-013

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Riclan S.a. for the product Freegells Cough Drops Menthol Honey Lemon (NDC 71165-013). 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 drug facts, active ingredient (in each drop), purpose, uses, warnings, ask a doctor before use if you have:, stop use ask doctor if, if pregnant or breast-feeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredient (In Each Drop)

Menthol 7.5 mg

Purpose

Cough suppressant/ Oral anesthetic

Uses

temporarily relieves:

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

Warnings

Sore throat warning: if sore throat is severe, persists for more than 2 days, is accompained or follwed 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 promtly. 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 accompained by excessive phlegm (mucus)

Stop Use 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 serius condition.
  • sore throat is severe, or irritation, pain o redness lasts or worsens
  • sore mouth does not improve in 7 days

If Pregnant Or Breast-Feeding,

ask a health professional before use.

Directions

 adults and children 5 years and over

 dissolve 1 lozenge slowly in mouth. Repeat every 2 hours as needed or as directed by a doctor.

 children under 5 years  ask a doctor 

Other Information

  • 11 calories per drop
  • do not use if bags is torn or open
  • Contains: Soy.

Inactive Ingredients:

beta carotene, corn syrup, eucalyptus oil, honey, natural & artificial flavors, soy lecithin, sucrose and water.

Package Labeling:71165-013-00

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Package Labeling:71165-013-01

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