Ludens Blue Raspberry Throat Drops
FDA Label NDC 52183-101

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 Blue Raspberry Throat Drops (NDC 52183-101). 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

                • 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       Ludens.com

1-866-583-3677       Ludens.com

1-866-583-3677       Ludens.com

1-866-583-3677 Ludens.com

Luden's Strawberry 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’s Blue Raspberry Throat 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’s Watermelon Throat Drops

Drug Facts

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

Luden’s Watermelon Throat Drops

Drug Facts

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

Questions Or Comments?

call 1-866-583-3677

Luden’s Wild Cherry Throat Drops

Drug Facts

call 1-866-583-3677

Luden's Strawberry 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 Throat Drops

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

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

Luden’s
Pectin Lozenge/Oral Demulcent
Blue Raspberry
20 Throat Drops

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 Throat Drops

Luden’spectin Lozenge/oral Demulcent Watermelon25 Throat Drops (Ludens Pectin Throat Lozenges 03)

Luden’spectin Lozenge/oral Demulcent Watermelon25 Throat Drops (Ludens Pectin Throat Lozenges 03)

Luden’s
Pectin Lozenge/Oral Demulcent
Watermelon
20 Throat Drops

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
Wild Berry
30 Drops

Luden’spectin Lozenge/oral Demulcentwild Berry30 Drops (Ludens Pectin Throat Lozenges 05)

Luden’spectin Lozenge/oral Demulcentwild Berry30 Drops (Ludens Pectin Throat Lozenges 05)






Luden’s
Pectin Lozenge

Oral Demulcent
Wild Ch
erry
14
Drops

Luden’spectin Lozengeoral Demulcentwild Cherry14 Drops (Ludens Pectin Throat Lozenges 06)

Luden’spectin Lozengeoral Demulcentwild Cherry14 Drops (Ludens Pectin Throat Lozenges 06)







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

Luden’spectin Lozenge/oral Demulcentwild Cherry30 Drops (Ludens Pectin Throat Lozenges 07)

Luden’spectin Lozenge/oral Demulcentwild Cherry30 Drops (Ludens Pectin Throat Lozenges 07)

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 08)

Luden’s Strawberry-bananapectin Lozenge / Oral Demulcent 20 Throat Drops (Ludens Pectin Throat Lozenges 08)

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

Luden’s Strawberry-bananapectin Lozenge / Oral Demulcent 25 Throat Drops (Ludens Pectin Throat Lozenges 09)

Luden’s Strawberry-bananapectin Lozenge / Oral Demulcent 25 Throat Drops (Ludens Pectin Throat Lozenges 09)

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 0a)

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

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