FDA Label for Ludens Watermelon Throat Drops

View Indications, Usage & Precautions

Ludens Watermelon Throat Drops Product Label

The following document was submitted to the FDA by the labeler of this product Prestige Brands Holdings, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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

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

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

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






Luden’s
Pectin Lozenge

Oral Demulcent
Wild Ch
erry
14
Drops







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

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

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

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


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