Ludens Honey Lemon Lozenge
FDA Label NDC 52183-220

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 Honey Lemon (NDC 52183-220). 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, stop use and ask a doctor if, directions, other information, inactive ingredients, 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

Purpose

Oral demulcent

Uses

for temporary relief of minor discomfort and protection of irritated areas in sore mouth and sore throat.

Warnings

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

Stop Use And Ask A Doctor If

  • sore mouth does not improve in 7 days
  • irritation, pain or redness persists or worsens

Directions

  • adults and children 3 years of age and older: allow one drop 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
  • Contains FD&C yellow no. 5 (tartrazine) as a color additive

Inactive Ingredients

ascorbic acid, citric acid, corn syrup, FD&C yellow no. 5, honey, lemon oil, sodium acetate, sodium chloride, sucrose, water

Questions?

1-866-583-3677  Ludens.com

Principal Display Panel

Luden’s ® 

Honey Lemon

Pectin lozenge/ oral demulcent

25 Throat Drops

Luden’s ® 

Honey Lemon

Pectin lozenge/ oral demulcent      

90 Throat Drops

Principal Display Panelluden’s ® Honey Lemonpectin Lozenge/ Oral Demulcent 25 Throat Drops Luden’s ® Honey Lemonpectin Lozenge/ Oral Demulcent 90 Throat Drops (Luden Honey Lemon 01)

Principal Display Panelluden’s ® Honey Lemonpectin Lozenge/ Oral Demulcent 25 Throat Drops Luden’s ® Honey Lemonpectin Lozenge/ Oral Demulcent 90 Throat Drops (Luden Honey Lemon 01)

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