Medique Sugar Free Medikoff Drops Lozenge
FDA Label NDC 47682-110

14 label sections · Submitted to the FDA by Unifirst First Aid Corporation · Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Unifirst First Aid Corporation for the product Medique Sugar Free Medikoff Drops (NDC 47682-110). 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 other, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - ask doctor, otc - stop use, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Otc - Active Ingredient

Active ingredient (in each drop)

Menthol 5.8 mg

Otc - Purpose

Purpose

Antitussive (cough suppressant)/oral anesthetic

Warnings

Warnings

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

Otc - Ask Doctor

Ask a doctor before use if you have

  • persistent or chronic cough such as occurs with smoking, asthma, or emphysema
  • cough accompanied by excessive phlegm (mucus)

Otc - Stop Use

Stop use and ask a doctor if

  • cough persists for more than 7 days, 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

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

Keep this and all drugs out of the reach of children.

Dosage & Administration

Directions

  • do not use more than directed

    • ​Adults and Children (12 years and older)

    ​Allow 1 drop to dissolve slowly in the mouth. May be repeated every 2 hours as necessary or as directed by a doctor.

    Children under 12 years: Ask a doctor

Other Safety Information

Other information

  • 7 calories per drop
  • store at 59°-86°F (15°-30°C)
  • protect from moisture & heat

Inactive Ingredient

Inactive ingredients

acesulfame potassium, eucalyptus oil, flavoring, isomalt

Otc - Questions

Questions or comments? 1-800-634-7680

* Please review the disclaimer below.