LUDENS MENTHOL THROAT DROPS (MENTHOL) LOZENGE LUDENS HONEY LICORICE THROAT DROPS (MENTHOL) LOZENGE LUDENS HONEY LEMON THROAT DROPS (MENTHOL) LOZENGE [PRESTIGE BRANDS HOLDINGS, INC.]

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  • LUDENS MENTHOL THROAT DROPS (MENTHOL) LOZENGE LUDENS HONEY LICORICE THROAT DROPS (MENTHOL) LOZENGE LUDENS HONEY LEMON THROAT DROPS (MENTHOL) LOZENGE [PRESTIGE BRANDS HOLDINGS, INC.]

LUDENS MENTHOL THROAT DROPS (MENTHOL) LOZENGE LUDENS HONEY LICORICE THROAT DROPS (MENTHOL) LOZENGE LUDENS HONEY LEMON THROAT DROPS (MENTHOL) LOZENGE [PRESTIGE BRANDS HOLDINGS, INC.]
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NDC 52183-255-30, 52183-259-20, 52183-266-30, 52183-269-20, 52183-278-20
Set ID 5dc2baec-a9ed-4f6b-a7ed-76a5d35739ac
Category HUMAN OTC DRUG LABEL
Packager Prestige Brands Holdings, Inc.
Generic Name
Product Class
Product Number
Application Number PART356
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  • 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)
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