Ludens Original Menthol Throat Drops
FDA Label NDC 52183-279

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 Original Menthol Throat Drops (NDC 52183-279). 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 luden's menthol throat drops, 2.5 mg, active ingredient (in each drop), purpose, uses, warnings, stop use and ask a doctor if:, if pregnant or breast-feeding,, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Luden's Menthol Throat Drops, 2.5 Mg

Drug Facts

Active Ingredient (In Each Drop)

Menthol 2.5 mg

Menthol 1.6 mg

Purpose

Oral anesthetic

Uses

  • 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 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.
        • allow1 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, glycerin, honey, 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 used as a processing aid, sucrose

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

Questions?

1-866-583-3677  Ludens.com

1-866-583-3677 Ludens.com

1-866-583-3677  Ludens.com

1-866-583-3677  Ludens.com

Luden's Honey Licorice Throat Drops, 1 Mg

Drug Facts

Active Ingredient (In Each Drop)

Menthol 1.0 mg

Menthol 1.6 mg

Purpose

Oral anesthetic

Oral anesthetic

Oral anesthetic

Oral anesthetic

Uses

  • temporarily relieves: occasional minor irritation, pain, sore mouth, and sore throat

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.

Directions

  • 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

Questions Or Comments?

call 1-866-583-3677

Luden’S Honey Licorice Throat Drops, 1.6 Mg

Drug Facts

Luden’S Honey Lemon Throat Drops, 1 Mg

Drug Facts

Active Ingredients

Menthol 1.0 mg

Luden’S Honey Lemon Throat Drops, 1.6 Mg

Drug Facts

Inactive Ingredients

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

Principal Display Panel

Luden's Menthol Sore Throat Drops, Menthol Oral Anesthetic

20 drops

Luden's Honey Licorice Sore Throat Drops, Menthol Oral Anesthetic

20 drops

Luden's Honey Licorice Sore Throat Drops, Menthol Oral Anesthetic

30 drops

Luden's Honey Lemon Sore Throat Drops, Menthol Oral Anesthetic

20 drops

Luden's Honey Lemon Sore Throat Drops, Menthol Oral Anesthetic

30 drops

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