Original Menthol And Eucalyptus Sugar Free
FDA Label NDC 84686-101

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Valda Usa Labeler for the product Original Menthol And Eucalyptus Sugar Free (NDC 84686-101). 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:

  • Minor sore throat
  • Cough due to minor throat and bronchial irritation as may occur with a cold or inhaled irritants

Warnings

Sore throat warning: If sore throat is severe and persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting, consult a doctor promptly.  These symptoms may be serious.

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.
  • Sore mouth does not improve in 2 days
  • Irritation, pain, or redness persists or worsens

Keep Out Of Reach Of Children.


Directions

  • Adults and children 5 years and over:  Dissolve 2 drops (one at a time) slowly in mouth.  Repeat every 2 hours as needed.
  • Children under 5 years of age: Ask a doctor.

Inactive Ingredients

Curcumin, eucalyptus globulus, FD&C Blue No. 1, glycerin, gum arabic, purified water, sorbitol, vegetable oil, white beeswax, xylitol

Questions?

Or to report adverse events call 1-877-349-9443

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