LUDENS ORIGINAL MENTHOL THROAT DROPS- menthol lozenge 
LUDENS HONEY LICORICE THROAT DROPS- menthol lozenge 
LUDENS HONEY LEMON THROAT DROPS- menthol lozenge 
Prestige Brands Holdings, Inc.

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.

----------

Ludens Menthol Throat Lozenges

Luden’s Original Menthol Throat Drops

Drug Facts

Active ingredient (in each drop)

Menthol 2.5 mg

Purpose

Oral anesthetic

Uses

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

Other information

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

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

Other information

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

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

Other information

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

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

Other information

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

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

Other information

Inactive ingredients

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

Questions?

1-866-583-3677 Ludens.com

PRINCIPAL DISPLAY PANEL 

LUDENS 
ORIGINAL MENTHOL
Menthol lozenge

Oral Anesthetic
14 Drops

LUDEN’S ORIGINAL MENTHOL Menthol lozenge Oral Anesthetic 14 Drops


Principal Display Panel

LUDENS 
HONEY LICORICE
Menthol lozenge/
Oral Anesthetic
20 Drops

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


Principal Display Panel

LUDENS 
HONEY LICORICE
Menthol lozenge

Oral Anesthetic
30 Drops

LUDEN’S HONEY LICORICE Menthol lozenge Oral Anesthetic 30 Drops


Principal Display Panel

LUDENS 
HONEY LEMON
Menthol lozenge

Oral Anesthetic
14 Drops

LUDEN’S HONEY LEMON Menthol lozenge Oral Anesthetic 14 Drops


Principal Display Panel

LUDENS 
HONEY LEMON
Menthol lozenge

Oral Anesthetic
30 Drops

LUDEN’S HONEY LEMON Menthol lozenge Oral Anesthetic 30 Drops
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)

Revised: 6/2020
Document Id: bdd552bf-5b1d-411b-8155-1efa4d420fbd
Set id: 5dc2baec-a9ed-4f6b-a7ed-76a5d35739ac
Version: 7
Effective Time: 20200630
 
Prestige Brands Holdings, Inc.