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  5. Label Information: Ludens Honey Licorice Throat Drops

FDA Label for Ludens Honey Licorice Throat Drops

View Indications, Usage & Precautions

Table of Contents

    1. LUDEN'S MENTHOL THROAT DROPS, 2.5 MG
    2. ACTIVE INGREDIENT (IN EACH DROP)
    3. PURPOSE
    4. USES
    5. WARNINGS
    6. STOP USE AND ASK A DOCTOR IF:
    7. IF PREGNANT OR BREAST-FEEDING,
    8. DIRECTIONS
    9. OTHER INFORMATION
    10. INACTIVE INGREDIENTS
    11. QUESTIONS?
    12. LUDEN'S HONEY LICORICE THROAT DROPS, 1 MG
    13. ACTIVE INGREDIENT (IN EACH DROP)
    14. PURPOSE
    15. USES
    16. STOP USE AND ASK A DOCTOR IF
    17. DIRECTIONS
    18. QUESTIONS OR COMMENTS?
    19. LUDEN’S HONEY LICORICE THROAT DROPS, 1.6 MG
    20. LUDEN’S HONEY LEMON THROAT DROPS, 1 MG
    21. ACTIVE INGREDIENTS
    22. LUDEN’S HONEY LEMON THROAT DROPS, 1.6 MG
    23. INACTIVE INGREDIENTS
    24. PRINCIPAL DISPLAY PANEL

Ludens Honey Licorice 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.

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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