Extra Strength With Natural Menthol Glacier Mint Cough Suppressant Lozenge
FDA Label NDC 54305-617

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Ricola Ag for the product Extra Strength With Natural Menthol Glacier Mint Cough Suppressant (NDC 54305-617). 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), uses, warnings, ask doctor before use if you have, stop use and ask a doctor if, keep out of reach of children., directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Purpose

Cough suppressant

Active Ingredient (In Each Drop)

Menthol, 8.3 mg

Uses

temporarily relieves:

  • cough due to minor throat and bronchial irritation occurring with a cold or inhaled irritants

Warnings

Ask Doctor Before Use If You Have

  • persistent 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 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache.  These could be signs of a serious condition

Keep Out Of Reach Of Children.


Directions

  • adults and children 6 years and older:  dissolve 1 drop slowly in the mouth.  Repeat every 2 hours as needed or as directed by a doctor
  • children under 6 years: ask a doctor

Other Information

Store in a dry place

Inactive Ingredients

extracts of peppermint and a Ricola herb mixture (elder, horehound, hyssop, lemon balm, linden flowers, mallow, peppermint, sage, thyme, wild thyme), glycerin, invert sugar (fructose/dextrose), natural flavor, starch syrup, sugar

Package Label.Principal Display Panel

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