Freegells Cough Drops Honey Lemon 30ct Lozenge
FDA Label NDC 83002-039

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Rl Albert & Son Inc. for the product Freegells Cough Drops Honey Lemon 30ct (NDC 83002-039). 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, keep out of reach of children., directions, other information, 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 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 accompanied by excessive phlegm (mucus)

    • Stop use and ask a 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.

Keep Out Of Reach Of Children.

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 (color), corn syrup, eucalyptus oil, honey, natural & artificial flavors, soy lecithin, sucrose and water

Product Label

Image Description (Image 39)

Image Description (Image 39)

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