Ludens Lozenge
FDA Label NDC 52183-227

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Prestige Brands Holdings, Inc. for the product Ludens (NDC 52183-227). 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, uses, warnings, ask a doctor before use if you have, stop use and ask a doctor if, directions, other information, 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)

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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