Ludens Wild Cherry Throat Drops Lozenge
FDA Label NDC 52183-229

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 Wild Cherry Throat Drops (NDC 52183-229). 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, questions?, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Active Ingredient (In Each Drop)

Pectin 2.8 mg

Pectin 1.7 mg

Pectin 2.8 mg

Pectin 1.7 mg

Pectin 2.8 mg

Pectin 1.7 mg

Pectin 2.8 mg

Pectin 1.7 mg

Pectin 2.8 mg

Purpose

Oral demulcent

Oral demulcent

Oral demulcent

Oral demulcent

Oral demulcent

Oral demulcent

Oral demulcent

Oral demulcent

Oral demulcent

Oral demulcent

Uses

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

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

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

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

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

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

        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.

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.

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 persists 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 persists 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 persists 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 persists 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 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
    • 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
      • 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
        • 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
          • 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
            • 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
              • 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
              • • 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

                • 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

                • 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
    • store at 20°-25°C (68°-77°F) in a dry place
      • store at 20°-25°C (68°-77°F) in a dry place
        • store at 20°-25°C (68°-77°F) in a dry place
          • store at 68°-77°F (20°-25°C) 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.
              • 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

                • 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

                • contains FD&C Yellow No. 5 (tartrazine)as a color additive

Questions?

1-866-583-3677      Ludens.com

1-866-583-3677      Ludens.com

1-866-583-3677

Luden’sWatermelonThroat Drops

Drug Facts

1-866-583-3677      Ludens.com

1-866-583-3677      Ludens.com

1-866-583-3677 Ludens.com

Luden'sStrawberry Banana Throat Drops

Drug Facts

1-866-583-3677 Ludens.com

Luden's Green Apple Throat Drops

Drug Facts

1-866-583-3677 Ludens.com

Inactive Ingredients

ascorbic acid, citric acid, corn syrup, FD&C blue no. 1, flavors, malic acid, sodium acetate, sodium chloride, soybean oil, sucrose, water

Luden’sBlue RaspberryThroat Drops

Drug Facts

ascorbic acid, citric acid, corn syrup, FD&C blue no. 1, flavors, malic acid, sodium acetate, sodium chloride, soybean oil, sucrose, water

Luden’sWatermelonThroat Drops

Drug Facts

ascorbic acid, citric acid, corn syrup, FD&C red no. 40, flavor, malic acid, sodium acetate, sodium chloride, soybean oil, sucrose, water

ascorbic acid, citric acid, corn syrup, FD&C red no. 40, flavors, malic acid, sodium acetate, sodium chloride, soybean oil, sucrose, water

Luden’s Wild Berry Throat Drops

Drug Facts

ascorbic acid, citric acid, corn syrup, FD&C blue 1, FD&C blue 2, FD&C red 40, flavors, malic acid, sodium acetate, sodium chloride, soybean oil, and sucrose.

Luden’s Wild Cherry Throat Drops

Drug Facts

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 used as a processing aid, Sucrose, Water

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 (processing aid), sucrose, water

citric acid, corn syrup, FD&C blue no. 2, FD&C red no. 40, FD&C yellow no. 6, flavors, malic acid, sodium acetate, sodium chloride, soybean oil, sucrose, water

citric acid, corn syrup, FD&C blue no. 2, FD&C red no. 40, FD&C yellow no. 6, flavors, malic acid, sodium acetate, sodium chloride, soybean oil, sucrose, water

citric acid, corn syrup, FD&C Blue No. 1, FD&C Yellow No. 5, flavor, malic acid, sodium acetate, sodium choride, sucrose, water

Stop Use And Ask A Doctor If:

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

Questions Or Comments?

call 1-866-583-3677

Luden’s Wild Cherry Throat Drops

Drug Facts

call 1-866-583-3677

Luden'sStrawberry Banana Throat Drops

Drug Facts

Active Ingredient (In Each Drop)

Pectin 2.8 mg

Principal Display Panel

Luden’s
Pectin Lozenge/Oral Demulcent
Blue Raspberry
25 ThroatDrops

Principal Display Panelluden’spectin Lozenge/oral Demulcent Blue Raspberry25 Throat Drops (Ludens Pectin Throat Lozenges 01)

Principal Display Panelluden’spectin Lozenge/oral Demulcent Blue Raspberry25 Throat Drops (Ludens Pectin Throat Lozenges 01)

Luden’s
Pectin Lozenge/Oral Demulcent
Blue Raspberry
20 ThroatDrops

Luden’spectin Lozenge/oral Demulcent Blue Raspberry20 Throat Drops (Ludens Pectin Throat Lozenges 02)

Luden’spectin Lozenge/oral Demulcent Blue Raspberry20 Throat Drops (Ludens Pectin Throat Lozenges 02)

Luden’s
Pectin Lozenge/Oral Demulcent
Watermelon
25 ThroatDrops

A Watermelon With A Barcodeai-generated Content May Be Incorrect. (Ludens Pectin Throat Lozenges 03)

A Watermelon With A Barcodeai-generated Content May Be Incorrect. (Ludens Pectin Throat Lozenges 03)

Luden’s
Pectin Lozenge/Oral Demulcent
Watermelon
20 ThroatDrops

Luden’spectin Lozenge/oral Demulcent Watermelon20 Throat Drops (Ludens Pectin Throat Lozenges 04)

Luden’spectin Lozenge/oral Demulcent Watermelon20 Throat Drops (Ludens Pectin Throat Lozenges 04)

Luden’s
Pectin Lozenge/Oral Demulcent
Watermelon

90 Throat
Drops

Principal Display Panel Luden’spectin Lozenge/oral Demulcent Watermelon90 Throat Drops (Ludens Pectin Throat Lozenges 05)

Principal Display Panel Luden’spectin Lozenge/oral Demulcent Watermelon90 Throat Drops (Ludens Pectin Throat Lozenges 05)

Luden’s
Pectin Lozenge/Oral Demulcent
Wild Berry
30 Drops

Luden’spectin Lozenge/oral Demulcentwild Berry30 Drops (Ludens Pectin Throat Lozenges 06)

Luden’spectin Lozenge/oral Demulcentwild Berry30 Drops (Ludens Pectin Throat Lozenges 06)






Luden’s
Pectin Lozenge

Oral Demulcent
Wild Ch
erry
14
Drops

Luden’spectin Lozengeoral Demulcentwild Cherry14 Drops (Ludens Pectin Throat Lozenges 07)

Luden’spectin Lozengeoral Demulcentwild Cherry14 Drops (Ludens Pectin Throat Lozenges 07)







Luden’s
Pectin Lozenge/Oral Demulcent
Wild Cherry
30 Drops

Principal Display Panel Luden’spectin Lozenge/oral Demulcentwild Cherry30 Drops (Ludens Pectin Throat Lozenges 08)

Principal Display Panel Luden’spectin Lozenge/oral Demulcentwild Cherry30 Drops (Ludens Pectin Throat Lozenges 08)

Luden’s
Pectin Lozenge/
Oral Demulcent
Wild Ch
erry
90
Drops

Principal Display Panel Luden’spectin Lozenge/oral Demulcentwild Cherry90 Drops (Ludens Pectin Throat Lozenges 09)

Principal Display Panel Luden’spectin Lozenge/oral Demulcentwild Cherry90 Drops (Ludens Pectin Throat Lozenges 09)

Luden’s
Pectin Lozenge/ Oral Demulcent
Wild Cherry
160 Drops

Luden’s Strawberry-Banana
Pectin lozenge / Oral Demulcent
20 Throat drops

Luden’s Strawberry-bananapectin Lozenge / Oral Demulcent 20 Throat Drops (Ludens Pectin Throat Lozenges 0a)

Luden’s Strawberry-bananapectin Lozenge / Oral Demulcent 20 Throat Drops (Ludens Pectin Throat Lozenges 0a)

Luden’s Strawberry-Banana
Pectin lozenge / Oral Demulcent
25Throat drops

Luden’s Strawberry-bananapectin Lozenge / Oral Demulcent 25 Throat Drops (Ludens Pectin Throat Lozenges 0b)

Luden’s Strawberry-bananapectin Lozenge / Oral Demulcent 25 Throat Drops (Ludens Pectin Throat Lozenges 0b)

Luden’s Green Apple
Pectin lozenge / Oral Demulcent
25
Throat drops

Luden’s Green Applepectin Lozenge / Oral Demulcent 25 Throat Drops (Ludens Pectin Throat Lozenges 0c)

Luden’s Green Applepectin Lozenge / Oral Demulcent 25 Throat Drops (Ludens Pectin Throat Lozenges 0c)

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