Ludens Sugar Free Wild Cherry Throat Lozenge
FDA Label NDC 52183-249

10 label sections · Submitted to the FDA by Prestige Brands Holdings, Inc. · 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 Sugar Free Wild Cherry Throat (NDC 52183-249). 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, 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

Inactive Ingredients

acesulfame potassium, citric acid, FD&C blue no.2, FD&C red no. 40, hydrogenated starch hydrolysate, isomalt, malic acid, soybean oil,water

Questionsor Comments?

call 1-866-583-3677 Ludens.com

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