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  5. Label Information: Medique Medikoff Drops

FDA Label for Medique Medikoff Drops

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT (IN EACH DROP)
    2. PURPOSES
    3. USES
    4. WARNINGS
    5. OTC - ASK DOCTOR
    6. OTC - STOP USE
    7. OTC - KEEP OUT OF REACH OF CHILDREN
    8. DIRECTIONS
    9. OTHER
    10. OTHER INFORMATION
    11. INACTIVE INGREDIENTS
    12. OTC - QUESTIONS
    13. PRINCIPAL DISPLAY PANEL - MEDIQUE MEDIKOFF BOX LABEL
    14. PRINCIPAL DISPLAY PANEL - MF CHERRY COUGH DROP BOX LABEL
    15. PRINCIPAL DISPLAY PANEL - MFP CHERRY COUGH DROP BOX LABEL

Medique Medikoff Drops Product Label

The following document was submitted to the FDA by the labeler of this product Unifirst First Aid Corporation. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredient (In Each Drop)



Menthol 7.6 mg


Purposes



Antitussive (cough suppressant)/oral anesthetic


Uses



Temporarily relieves

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

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.


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 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


Otc - Keep Out Of Reach Of Children



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


Directions



  • do not use more than directed

Other



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



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

Inactive Ingredients



cherry flavor, corn syrup, eucalyptus oil, FD&C red #40 lake, sucrose


Otc - Questions



Questions or comments? 1-800-634-7680


Principal Display Panel - Medique Medikoff Box Label



Medique ®
Medikoff Drops
Vapor Action

Accion de Vapor

Pull to Open

Tire Para Abrir

Cough Suppressant/Anesthetic Menthol 7.6mg

Suprime la tos/anestesico Mentol 7.6mg
Cherry Flavor

Sabor a Ceresa
75
Drops
(75 x 1)


Principal Display Panel - Mf Cherry Cough Drop Box Label



125

Drops

Medi-First ® Cherry Cough Drops

Pastillas parala tos sabor cereza

Vapor Action/accion de vapor

Pull to Open

Tire Para Abrir

Cough Suppressant Menthol 7.6mg

Suprime la tos Mentol 7.6mg

Compare active ingredient to:

Compare el ingrediente activo con:

Halls ® Registered Trademark of Warner-Lambert

Marca Registrada de WarnerLambert

IndividuallyWrapped Cough Drops

Individualmente Envuelto

Gotas para la Tos


Principal Display Panel - Mfp Cherry Cough Drop Box Label



50 Drops

50 Gotas

Medi First ® Plus

Cherry Cough Drops

Gotas de Cereza

Para la Tos

Pull To Open

Cough Suppressant with Vapor Action

Suprime la tos con accion de vapor

Compare active ingredient to:

Halls ® Registered Trademark of Warner-Lambert

IndividuallyWrapped Cough Drops

Individualmente Envuelto Gotas

[email protected]


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