Active Ingredient (In Each Drop)
Pectin 2.8 mg
Ludens Assorted Flavors
FDA Label NDC 52183-217
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 Assorted Flavors (NDC 52183-217). 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
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
Inactive Ingredients
Wild Cherry: ascorbic acid, citric acid, corn syrup, FD&C blue no. 2, FD&C red no. 40, flavors, malic acid, sodium acetate, sodium chloride, soybean oil, sucrose, water
Watermelon: ascorbic acid, citric acid, corn syrup, FD&C red no. 40, flavors, malic acid, sodium acetate, sodium chloride, soybean oil, sucrose, water
Honey & Berry: caramel color, citric acid, corn syrup, FD&C blue no. 1, FD&C red no. 40, flavor, honey, sodium acetate, sodium chloride, soybean oil, sucrose, water
Questions?
1-866-583-3677 Ludens.com
Principal Display Panel
Luden’s
Pectin Lozenge/ Oral Demulcent
Assorted flavors
Wild Cherry • Watermelon • Honey & Berry
90 Throat Drops
Principal Display Panelluden’spectin Lozenge/ Oral Demulcentassorted Flavors Wild Cherry • Watermelon • Honey & Berry 90 Throat Drops (Ludens Assorted Flavors 01)
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