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  5. Label Information: Ludens Dual Relief

FDA Label for Ludens Dual Relief

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT (IN EACH DROP)
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. ASK A DOCTOR BEFORE USE IF YOU HAVE
    6. STOP USE AND ASK A DOCTOR IF
    7. DIRECTIONS
    8. OTHER INFORMATION
    9. INACTIVE INGREDIENTS
    10. QUESTIONS?
    11. PRINCIPAL DISPLAY PANEL

Ludens Dual Relief Product Label

The following document was submitted to the FDA by the labeler of this product Prestige Brands Holdings, Inc.. 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)



Pectin 2.8 mg 

Menthol 2.5 mg


Purpose



Oral demulcent

Cough suppressant


Uses



temporarily relieves:

  • minor discomfort and protection of irritated areas in sore mouth and sore throat
  • cough associated with a cold or inhaled irritants.

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 may be serious.  


Ask A Doctor Before Use If You Have



  • cough that lasts or is chronic such as occurs with smoking, asthma, or emphysema
  • cough that occurs with too much phlegm (mucus)

Stop Use And Ask A Doctor If



  • sore mouth symptoms do not improve in 7 days
  • cough lasts more than 7 days, tends to recur, or occurs with fever, rash, or persistent headache. These could be signs of a serious condition.

Directions



  • adults and children 3 years of age and older: allow two drops to dissolve slowly in mouth
  • may be repeated as needed or as directed by a doctor
  • children under 3 years of age: ask a doctor

Other Information



store at 20°-25°C (68°-77°F) in a dry place


Inactive Ingredients



corn syrup, FD&C blue no. 2, FD&C red no. 40, flavor, propylene glycol, sodium acetate, sodium chloride, soybean oil, sucrose, water


Questions?



1-866-583-3677  Ludens.com

Distributed by Medtech Products Inc.
Tarrytown, NY 10591
A Prestige Brands Company
©2018 Trade dress is owned by Medtech Products Inc. All rights reserved.


Principal Display Panel



Luden’s®

Cough Suppressant/Oral Demulcent

DUAL RELIEF

Wild Cherry

25 Cough Drops

PRINCIPAL DISPLAY PANELLuden’s®Cough Suppressant/Oral DemulcentDUAL RELIEF Wild Cherry25 Cough Drops - ludens dual relief 01

PRINCIPAL DISPLAY PANELLuden’s®Cough Suppressant/Oral DemulcentDUAL RELIEF Wild Cherry25 Cough Drops - ludens dual relief 01


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