Ludens Honey Licorice Throat Drops
FDA Label NDC 52183-259

13 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 Honey Licorice Throat Drops (NDC 52183-259). 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:, if pregnant or breast-feeding,, 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)

Menthol 2.5 mg

Menthol 1.0 mg

Menthol 1.6 mg

Menthol 1.0 mg

Menthol 1.6 mg

Purpose

Oral anesthetic

Oral anesthetic

Oral anesthetic

Oral anesthetic

Oral anesthetic

Uses

  • temporarily relieves: occasional minor irritation, pain, sore mouth, and sore throat
    • temporarily relieves: occasional minor irritation, pain, sore mouth, and sore throat
      • for temporary relief of occasional minor irritation, pain, sore mouth, and sore throat
        • temporarily relieves: occasional minor irritation, pain, sore mouth, and sore throat
          • for temporary relief of occasional minor irritation, pain, 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.

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.

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.

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.

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 lasts or worsens.

If Pregnant Or Breast-Feeding,

ask a doctor before use.

ask a doctor before use.

ask a health professional before use.

ask a doctor before use.

ask a health professional before use.

Directions

  • adults and children 3 years of age and older:allow drop to dissolve slowly in mouth. Repeat as necessary every 2 hours, or as directed by doctor.
  • children under 3 years of age:ask a doctor
    • adults and children 3 years of age and older: allow  2 drops to dissolve slowly in mouth. Repeat as necessary every 2 hours, or as directed by a doctor.
    • children under 3 years of age:ask a doctor
      • Adults and children 3 years of age and older:
      • allow  1 drop at a time to dissolve slowly in mouth. Repeat as necessary every 2 hours, or as directed by a doctor.
      • Children under 3 years of age:ask a doctor
        • adults and children 3 years of age and older: allow 2 drops to dissolve slowly in mouth. Repeat as necessary every 2 hours, or as directed by a doctor.
        • children under 3 years of age:ask a doctor
          • Adults and children 3 years of age and older:2 drops.
          • allow  1 drop at a time to dissolve slowly in mouth. Repeat as necessary every 2 hours, 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
  • Do not use if clear outer wrap is opened or missing.
    • store at 20-25°C (68-77°F) in a dry place
    • do not use if clear outer wrap is opened or missing.
      • store at 20-25°C (68-77°F) in a dry place
        • store at 20-25°C (68-77°F) in a dry place
        • do not use if clear outer wrap is opened or missing.
        • contains FD&C yellow no. 5 (tartrazine) as a color additive
          • 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

Caramel Color, Corn Syrup, Flavors, Sodium Acetate, Soybean Oil used as a processing aid, Sucrose, Water

Caramel Color, Corn Syrup, Flavors, Glycerin, Honey, Sodium Acetate, Soybean Oil used as a processing aid, Sucrose, Water

caramel color, corn syrup, flavors, glycerin, honey, sodium acetate, soybean oil, sucrose.

ascorbic acid, citric acid, corn syrup, FD&C yellow 5, flavors, honey, sodium acetate, sodium chloride, soybean oil, sucrose

caramel color, corn syrup, flavors, glycerin, honey, sodium acetate, soybean oil, sucrose.

Questions Or Comments?

Call 1-866-583-3677

Luden’s Honey Licorice Throat Drops

Drug Facts

call 1-866-583-3677

Luden’s Honey Licorice Throat Drops

Drug Facts

Stop Use And Ask A Doctor If

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

Questions?

1-866-583-3677Ludens.com

Luden’s Honey Lemon Throat Drops

Drug Facts

1-866-583-3677Ludens.com

Luden’s Honey Lemon Throat Drops

Drug Facts

1-866-583-3677Ludens.com

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