Throat Comfort Orange Mint Cinnamon Drops Lozenge
FDA Label NDC 63667-342

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 Throat Comfort Orange Mint Cinnamon Drops (NDC 63667-342). 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, Oral anesthetic

Active Ingredient (In Each Drop)

Menthol, 3.6 mg

Uses

temporarily relieves:

  • cough due to a cold or inhaled irritants
  • occasional minor irritation and pain due to sore throat or sore mouth

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,
  • do not use in children under 6 years of age unless directed by a doctor.

Ask 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 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache.  These could be signs of a serious condition.
  • sore mouth does not improve in 7 days
  • irritation, pain, or redness persists or worsens

Keep Out Of Reach Of Children.

Directions

  • adults and children 6 years and older:  dissolve 2 drops (one at a time) 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

protect from heat and moisture

Inactive Ingredients

capsicum extract, cinnamon extract, citric acid, color (beta-carotene), extracts of lemon balm and a Ricola’s herb mixture (elder, horehound, hyssop, lemon balm, linden flowers, mallow, peppermint, sage, thyme, wild thyme), glucose syrup, glucose-fructose syrup, glycerin, honey, natural flavors, orange juice concentrate, peppermint oil, sugar

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