Label: LUDENS ORIGINAL MENTHOL THROAT DROPS- menthol lozenge LUDENS HONEY LICORICE THROAT DROPS- menthol lozenge LUDENS HONEY LEMON THROAT DROPS- menthol lozenge 

  • Label RSS
  • NDC Code(s): 52183-255-30, 52183-259-14, 52183-266-30, 52183-269-14, view more
    52183-279-14
  • Packager: Prestige Brands Holdings, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 08/12

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Luden’s Original Menthol Throat Drops

    Drug Facts

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  • Active ingredient (in each drop)

    Menthol 2.5 mg

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  • Purpose

    Oral anesthetic

    Close
  • Uses

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

    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.

    Keep out of reach of children

    Close
  • 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
    Close
  • Other information

    • store at 20-25ºC (68-77ºF) in a dry place
    • Do not use if clear outer wrap is opened or missing.
    Close
  • Inactive ingredients

    Caramel Color, Corn Syrup, Flavors, Sodium Acetate, Soybean Oil used as a processing aid, Sucrose, Water

    Close
  • Questions or comments?

    Call 1-866-583-3677






    Luden’s Honey Licorice Throat Drops

    Drug Facts

    Close
  • Active ingredient (in each drop)

    Menthol 1.0 mg

    Close
  • Purpose

    Oral anesthetic

    Close
  • Uses

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

    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.

    Keep out of reach of children

    Close
  • 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
    Close
  • Other information

    • store at 20-25ºC (68-77ºF) in a dry place
    • do not use if clear outer wrap is opened or missing.
    Close
  • Inactive ingredients

    Caramel Color, Corn Syrup, Flavors, Glycerin, Honey, Sodium Acetate, Soybean Oil used as a processing aid, Sucrose, Water

    Close
  • Questions or comments?

    call 1-866-583-3677





     
    Luden’s Honey Licorice Throat Drops

    Drug Facts

    Close
  • Active ingredient (in each drop)

    Menthol 1.6 mg

    Close
  • Purpose

    Oral anesthetic

    Close
  • Uses

    • for temporary relief of occasional minor irritation, pain, sore mouth, and sore throat
    Close
  • 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.

    Stop use and ask a doctor if

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

    If pregnant or breast-feeding,

    ask a health professional before use.

    Keep out of reach of children

    Close
  • Directions

    • Adults and children 3 years of age and older:
    • allow 1 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
    Close
  • Other information

    • store at 20-25ºC (68-77ºF) in a dry place
    Close
  • Inactive ingredients

    caramel color, corn syrup, flavors, glycerin, honey, sodium acetate, soybean oil, sucrose.

    Close
  • Questions?

    1-866-583-3677 Ludens.com





       
    Luden’s Honey Lemon Throat Drops

    Drug Facts

    Close
  • Active ingredient (in each drop)

    Menthol 1.0 mg

    Close
  • Purpose

    Oral anesthetic

    Close
  • Uses

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

    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.

    Keep out of reach of children

    Close
  • 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
    Close
  • Other information

    • store at 20-25ºC (68-77ºF) 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
    Close
  • Inactive ingredients

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

    Close
  • Questions?

    1-866-583-3677 Ludens.com






    Luden’s Honey Lemon Throat Drops

    Drug Facts

    Close
  • Active ingredient (in each drop)

    Menthol 1.6 mg

    Close
  • Purpose

    Oral anesthetic

    Close
  • Uses

    • for temporary relief of occasional minor irritation, pain, sore mouth, and sore throat
    Close
  • 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.

    Stop use and ask a doctor if

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

    If pregnant or breast-feeding,

    ask a health professional before use.

    Keep out of reach of children

    Close
  • Directions

    • Adults and children 3 years of age and older: 2 drops.
    • allow 1 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
    Close
  • Other information

    • store at 20-25ºC (68-77ºF) in a dry place
    • contains FD&C yellow no. 5 (tartrazine) as a color additive
    Close
  • Inactive ingredients

    caramel color, corn syrup, flavors, glycerin, honey, sodium acetate, soybean oil, sucrose.

    Close
  • Questions?

    1-866-583-3677 Ludens.com





    Close
  • PRINCIPAL DISPLAY PANEL 

    LUDENS 
    ORIGINAL MENTHOL
    GREAT TASTING THROAT DROPS
    Menthol lozenge

    Oral Anesthetic
    Soothes Everyday Throat Irritation 14 Drops

    Principal Display Panel
Luden's Original Menthol Throat Drops


    Close
  • Principal Display Panel

    LUDENS 
    HONEY LICORICE
    GREAT TASTING THROAT DROPS

    Menthol lozenge

    Oral Anesthetic
    Soothes Everyday Throat Irritation 14 Drops

    Principal Display Panel
Luden's Honey Licorice Throat Drops

    Close
  • Principal Display Panel

    LUDENS 
    HONEY LICORICE
    GREAT TASTING THROAT DROPS

    Menthol lozenge

    Oral Anesthetic
    Sooth
    es Everyday Throat Irritation 30 Drops

    Principal Display Panel
Honey Licorice Throat Drops


    Close
  • Principal Display Panel

    LUDENS 
    HONEY LEMON
    GREAT TASTING THROAT DROPS

    Menthol lozenge

    Oral Anesthetic
    Soothes Everyday Throat Irritation 14 Drops

    Principal Display Panel
Honey Lemon Throat Drops


    Close
  • Principal Display Panel

    LUDENS 
    HONEY LEMON
    GREAT TASTING THROAT DROPS

    Menthol lozenge

    Oral Anesthetic
    Soothes Everyday Throat Irritation 14 Drops

    Principal Display Panel
Honey Lemon Throat Drops

    Close
  • INGREDIENTS AND APPEARANCE
    LUDENS ORIGINAL MENTHOL THROAT DROPS 
    menthol lozenge
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:52183-279
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MENTHOL (MENTHOL) MENTHOL 2.5 mg
    Inactive Ingredients
    Ingredient Name Strength
    CORN SYRUP  
    SODIUM ACETATE  
    SOYBEAN OIL  
    SUCROSE  
    Product Characteristics
    Color BROWN Score no score
    Shape CAPSULE Size 22mm
    Flavor MENTHOL Imprint Code LUDENS
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:52183-279-14 14 in 1 CARTON
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part356 10/29/2009
    LUDENS HONEY LICORICE THROAT DROPS 
    menthol lozenge
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:52183-259
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MENTHOL (MENTHOL) MENTHOL 1.0 mg
    Inactive Ingredients
    Ingredient Name Strength
    CORN SYRUP  
    SODIUM ACETATE  
    SOYBEAN OIL  
    SUCROSE  
    GLYCERIN  
    HONEY  
    Product Characteristics
    Color BLACK Score no score
    Shape CAPSULE Size 22mm
    Flavor LICORICE Imprint Code LUDENS
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:52183-259-14 14 in 1 CARTON
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part356 10/29/2009
    LUDENS HONEY LEMON THROAT DROPS 
    menthol lozenge
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:52183-269
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MENTHOL (MENTHOL) MENTHOL 1.0 mg
    Inactive Ingredients
    Ingredient Name Strength
    CORN SYRUP  
    SODIUM ACETATE  
    SOYBEAN OIL  
    SUCROSE  
    HONEY  
    ASCORBIC ACID  
    CITRIC ACID MONOHYDRATE  
    FD&C YELLOW NO. 5  
    SODIUM CHLORIDE  
    Product Characteristics
    Color YELLOW Score no score
    Shape CAPSULE Size 22mm
    Flavor LEMON Imprint Code LUDENS
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:52183-269-14 14 in 1 CARTON
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part356 10/29/2009
    LUDENS HONEY LICORICE THROAT DROPS 
    menthol lozenge
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:52183-255
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MENTHOL (MENTHOL) MENTHOL 1.6 mg
    Inactive Ingredients
    Ingredient Name Strength
    CORN SYRUP  
    SODIUM ACETATE  
    SOYBEAN OIL  
    SUCROSE  
    GLYCERIN  
    HONEY  
    Product Characteristics
    Color BLACK Score no score
    Shape CAPSULE Size 22mm
    Flavor LICORICE Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:52183-255-30 30 in 1 BAG
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part356 10/29/2009
    LUDENS HONEY LEMON THROAT DROPS 
    menthol lozenge
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:52183-266
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MENTHOL (MENTHOL) MENTHOL 1.6 mg
    Inactive Ingredients
    Ingredient Name Strength
    CORN SYRUP  
    SODIUM ACETATE  
    SOYBEAN OIL  
    SUCROSE  
    HONEY  
    ASCORBIC ACID  
    CITRIC ACID MONOHYDRATE  
    FD&C YELLOW NO. 5  
    SODIUM CHLORIDE  
    Product Characteristics
    Color YELLOW Score no score
    Shape CAPSULE Size 22mm
    Flavor LEMON Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:52183-266-30 30 in 1 BAG
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part356 10/29/2009
    Labeler - Prestige Brands Holdings, Inc. (159655021)
    Establishment
    Name Address ID/FEI Business Operations
    BestSweet Inc. 002149136 MANUFACTURE(52183-269, 52183-259, 52183-279, 52183-255, 52183-266)
    Close