Cough Drops Gems Flawless Honey Lemon Flavor 30ct Lozenge
FDA Label NDC 71165-033

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 Cough Drops Gems Flawless Honey Lemon Flavor 30ct (NDC 71165-033). 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, warnings, 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

Menthol 9mg

Purpose

Cough Suppressant / Oral anesthetic

Use

Temporarily relieves:

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

Warnings

Sore throat warning: Severe or persistent sore throat or sore throat accompanied by high fever, headache, rash, swelling, nausea, or vomiting may be serious. Consult a doctor Promptly. Do not use more than 2 days unless directed by a doctor.

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 1 week , 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

Keep Out Of Reach Of Children

Directions

  • do not take more than directed 
  • adults and children 5 years and over : dissolve 1 drop slowly in the mouth. Repeate every 2 hours as needed.
  • children under 5 years : ask a doctor

Other Information

  • 12 calories per drop 
  • Contains : Soy

Inactive Ingredients

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

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Product Label

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