Ricola Max Nasal Care Cool Menthol Lozenge
FDA Label NDC 63667-206

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 Usa Inc. for the product Ricola Max Nasal Care Cool Menthol (NDC 63667-206). 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, 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

Drug Facts

Purpose

Oral anesthetic

Active Ingredient (In Each Drop)

Menthol, 15.3 mg

Uses

temporarily relieves occasional minor irritation and pain associated with:

  • sore mouth
  • sore throat

Warnings

​Sore throat warnings:

  • 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.  These may be serious.

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
  • do not bite or chew

Other Information

Store in a dry place

Inactive Ingredients

extract of lemon balm and the Ricola herb mixture (elder, horehound, hyssop, lemon balm, linden flowers, mallow, peppermint, sage, thyme, wild thyme), colors (carrot, spirulina), flavors (lemon-thyme, peppermint), starch syrup, sugar

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