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

Full FDA labeling including 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 active ingredient (in each drop), purpose, temporarily relieves, other, ask a doctor before use if you have, stop use and ask a doctor if, otc - pregnancy or breast feeding, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient (In Each Drop)

Menthol 5.8 mg

Purpose

Antitussive (cough suppressant)/oral anesthetic

Temporarily Relieves

  • cough as may occur with a cold or inhaled irritants
  • occasional minor irritation and sore throat

Other

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.

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)

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.

Otc - Pregnancy Or Breast Feeding

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

Directions

  • do not use more than directed
  • do not use for more than 2 days

Adults And Children: (12 Years And Older)

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

Children Under 12 Years:

Do not give to children under 12 years of age.

Other Information

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

Inactive Ingredients:

acesulfame potassium, eucalyptus oil, flavoring, hydrogenated starch hydrolysate*, isomalt, peppermint oil, soy bean oil*, sucralose*, water*

May contain*

Package Label.Principal Display Panel

109R Medique SF Medikoff Label

Medique®

Collect MediBucks

See inside flap for more details

Sugar Free

Medikoff

Drops

Vapor Action / Cough Suppressant

Accion de Vapor / Suprime la Tos

Vapor Action

Accion Vaporizante

Menthol/Eucalyptus

Mentol/Eucalypto

Pull to Open

Tire Para Abrir

300 Lozenges

(300 x 1)

* Please review the disclaimer below.