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

  • NDC Code(s): 52183-255-30, 52183-259-14, 52183-259-20, 52183-266-30, view more
    52183-269-14, 52183-269-30, 52183-279-14
  • Packager: Prestige Brands Holdings, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by 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 February 25, 2016

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

  • SPL UNCLASSIFIED SECTION

    Luden’s Original Menthol Throat Drops

    Drug Facts

    Close
  • Active ingredient (in each drop)

    Menthol 2.5 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 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
    Menthol lozenge

    Oral Anesthetic
    14 Drops

    LUDEN’S 
ORIGINAL MENTHOL
Menthol lozenge
Oral Anesthetic
14 Drops


    Close
  • Principal Display Panel

    LUDENS 
    HONEY LICORICE
    Menthol lozenge/
    Oral Anesthetic
    20 Drops

    LUDEN’S 
HONEY LICORICE
Menthol lozenge/Oral Anesthetic
20 Drops

    Close
  • Principal Display Panel

    LUDENS 
    HONEY LICORICE
    Menthol lozenge

    Oral Anesthetic
    30 Drops

    LUDEN’S 
HONEY LICORICE
Menthol lozenge
Oral Anesthetic
30 Drops


    Close
  • Principal Display Panel

    LUDENS 
    HONEY LEMON
    Menthol lozenge

    Oral Anesthetic
    14 Drops

    LUDEN’S 
HONEY LEMON
Menthol lozenge
Oral Anesthetic
14 Drops


    Close
  • Principal Display Panel

    LUDENS 
    HONEY LEMON
    Menthol lozenge

    Oral Anesthetic
    30 Drops

    LUDEN’S 
HONEY LEMON
Menthol lozenge
Oral Anesthetic
30 Drops

    Close
  • INGREDIENTS AND APPEARANCE
    LUDENS ORIGINAL MENTHOL THROAT DROPS 
    menthol lozenge
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:52183-279
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM 2.5 mg
    Inactive Ingredients
    Ingredient Name Strength
    CORN SYRUP (UNII: 9G5L16BK6N)  
    SODIUM ACETATE (UNII: 4550K0SC9B)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    SUCROSE (UNII: C151H8M554)  
    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; Type 0: Not a Combination Product
    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 Item Code (Source) NDC:52183-259
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM 1.0 mg
    Inactive Ingredients
    Ingredient Name Strength
    CORN SYRUP (UNII: 9G5L16BK6N)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HONEY (UNII: Y9H1V576FH)  
    SODIUM ACETATE (UNII: 4550K0SC9B)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    SUCROSE (UNII: C151H8M554)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Color BLACK Score no score
    Shape CAPSULE Size 21mm
    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; Type 0: Not a Combination Product
    2 NDC:52183-259-20 20 in 1 BOX; Type 0: Not a Combination Product
    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 Item Code (Source) NDC:52183-269
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM 1.0 mg
    Inactive Ingredients
    Ingredient Name Strength
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    CORN SYRUP (UNII: 9G5L16BK6N)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    HONEY (UNII: Y9H1V576FH)  
    SODIUM ACETATE (UNII: 4550K0SC9B)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    SUCROSE (UNII: C151H8M554)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Color YELLOW Score no score
    Shape CAPSULE Size 23mm
    Flavor LEMON (Honey 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; Type 0: Not a Combination Product
    2 NDC:52183-269-30 30 in 1 BAG; Type 0: Not a Combination Product
    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 Item Code (Source) NDC:52183-255
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM 1.6 mg
    Inactive Ingredients
    Ingredient Name Strength
    CORN SYRUP (UNII: 9G5L16BK6N)  
    SODIUM ACETATE (UNII: 4550K0SC9B)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    SUCROSE (UNII: C151H8M554)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HONEY (UNII: Y9H1V576FH)  
    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; Type 0: Not a Combination Product
    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 Item Code (Source) NDC:52183-266
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM 1.6 mg
    Inactive Ingredients
    Ingredient Name Strength
    CORN SYRUP (UNII: 9G5L16BK6N)  
    SODIUM ACETATE (UNII: 4550K0SC9B)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    SUCROSE (UNII: C151H8M554)  
    HONEY (UNII: Y9H1V576FH)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    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; Type 0: Not a Combination Product
    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)
    Close