Freegells Cough Drops Menthol Strawberry 30 Drops Suspension/ Drops
FDA Label NDC 83002-001

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 Strawberry 30 Drops (NDC 83002-001). 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, directions, other information, inactive ingredients, product label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

 Menthol 2.7mg

Purpose

Cough Suppressant / Oral anesthetic

Use

  • 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.

Directions

Adults and children 5 years and over

dissolve 2 lozenges (one at a time) 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 bag is torn or open 
  • Contains : Soy

Inactive Ingredients

Citric acid, corn syrup, eucalyptus oil, FD&C red no. 40, natural & artificial flavoring, soy lecithin, sucrose and water.

Product Label

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