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 June 30, 2020

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

View All Sections
  • SPL UNCLASSIFIED SECTION

    Luden’s Original Menthol Throat Drops

    Drug Facts

  • Active ingredient (in each drop)

    Menthol 2.5 mg

  • Purpose

    Oral anesthetic

  • Uses

    • temporarily relieves: 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.

    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

  • 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
  • Other information

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

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

  • Questions or comments?

    Call 1-866-583-3677

    Luden’s Honey Licorice Throat Drops

    Drug Facts

  • Active ingredient (in each drop)

    Menthol 1.0 mg

  • Purpose

    Oral anesthetic

  • Uses

    • temporarily relieves: 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.

    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

  • 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
  • Other information

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

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

  • Questions or comments?

    call 1-866-583-3677

    Luden’s Honey Licorice Throat Drops

    Drug Facts

  • Active ingredient (in each drop)

    Menthol 1.6 mg

  • Purpose

    Oral anesthetic

  • Uses

    • 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.

    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

  • 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
  • Other information

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

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

  • Questions?

    1-866-583-3677 Ludens.com

    Luden’s Honey Lemon Throat Drops

    Drug Facts

  • Active ingredient (in each drop)

    Menthol 1.0 mg

  • Purpose

    Oral anesthetic

  • Uses

    • temporarily relieves: 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.

    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

  • 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
  • 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
  • Inactive ingredients

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

  • Questions?

    1-866-583-3677 Ludens.com

    Luden’s Honey Lemon Throat Drops

    Drug Facts

  • Active ingredient (in each drop)

    Menthol 1.6 mg

  • Purpose

    Oral anesthetic

  • Uses

    • 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.

    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

  • 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
  • Other information

    • store at 20-25ºC (68-77ºF) 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, sucrose.

  • Questions?

    1-866-583-3677 Ludens.com

  • PRINCIPAL DISPLAY PANEL 

    LUDEN’S 
    ORIGINAL MENTHOL
    Menthol lozenge
    Oral Anesthetic
    14 Drops

    LUDEN’S ORIGINAL MENTHOL Menthol lozenge Oral Anesthetic 14 Drops


  • Principal Display Panel

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

    LUDEN’S HONEY LICORICE Menthol lozenge/Oral Anesthetic 20 Drops
  • Principal Display Panel

    LUDEN’S 
    HONEY LICORICE
    Menthol lozenge
    Oral Anesthetic
    30 Drops

    LUDEN’S HONEY LICORICE Menthol lozenge Oral Anesthetic 30 Drops


  • Principal Display Panel

    LUDEN’S 
    HONEY LEMON
    Menthol lozenge
    Oral Anesthetic
    14 Drops

    LUDEN’S HONEY LEMON Menthol lozenge Oral Anesthetic 14 Drops


  • Principal Display Panel

    LUDEN’S 
    HONEY LEMON
    Menthol lozenge
    Oral Anesthetic
    30 Drops

    LUDEN’S HONEY LEMON Menthol lozenge Oral Anesthetic 30 Drops
  • INGREDIENTS AND APPEARANCE
    LUDENS ORIGINAL MENTHOL THROAT DROPS 
    menthol lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52183-279
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL2.5 mg
    Inactive Ingredients
    Ingredient NameStrength
    CORN SYRUP (UNII: 9G5L16BK6N)  
    SODIUM ACETATE (UNII: 4550K0SC9B)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    SUCROSE (UNII: C151H8M554)  
    Product Characteristics
    ColorBROWNScoreno score
    ShapeCAPSULESize22mm
    FlavorMENTHOLImprint Code LUDENS
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52183-279-1414 in 1 CARTON; Type 0: Not a Combination Product10/29/200908/31/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35610/29/200908/31/2017
    LUDENS HONEY LICORICE THROAT DROPS 
    menthol lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52183-259
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1.0 mg
    Inactive Ingredients
    Ingredient NameStrength
    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
    ColorBLACKScoreno score
    ShapeCAPSULESize21mm
    FlavorLICORICEImprint Code LUDENS
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52183-259-1414 in 1 CARTON; Type 0: Not a Combination Product10/29/2009
    2NDC:52183-259-2020 in 1 BOX; Type 0: Not a Combination Product10/29/2009
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35610/29/2009
    LUDENS HONEY LEMON THROAT DROPS 
    menthol lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52183-269
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1.0 mg
    Inactive Ingredients
    Ingredient NameStrength
    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
    ColorYELLOWScoreno score
    ShapeCAPSULESize23mm
    FlavorLEMON (Honey Lemon) Imprint Code LUDENS
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52183-269-1414 in 1 CARTON; Type 0: Not a Combination Product10/29/200908/31/2021
    2NDC:52183-269-3030 in 1 BAG; Type 0: Not a Combination Product10/29/200908/31/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35610/29/200908/31/2021
    LUDENS HONEY LICORICE THROAT DROPS 
    menthol lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52183-255
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1.6 mg
    Inactive Ingredients
    Ingredient NameStrength
    CORN SYRUP (UNII: 9G5L16BK6N)  
    SODIUM ACETATE (UNII: 4550K0SC9B)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    SUCROSE (UNII: C151H8M554)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HONEY (UNII: Y9H1V576FH)  
    Product Characteristics
    ColorBLACKScoreno score
    ShapeCAPSULESize22mm
    FlavorLICORICEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52183-255-3030 in 1 BAG; Type 0: Not a Combination Product10/29/2009
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35610/29/2009
    LUDENS HONEY LEMON THROAT DROPS 
    menthol lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52183-266
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1.6 mg
    Inactive Ingredients
    Ingredient NameStrength
    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
    ColorYELLOWScoreno score
    ShapeCAPSULESize22mm
    FlavorLEMONImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52183-266-3030 in 1 BAG; Type 0: Not a Combination Product10/29/200908/31/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35610/29/200908/31/2021
    Labeler - Prestige Brands Holdings, Inc. (159655021)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!