Your browser does not support JavaScript! 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.]
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RxNorm Names

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.]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE: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 Sections

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 

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


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


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


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


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

LUDENS ORIGINAL MENTHOL THROAT DROPS 
menthol lozenge
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:52183-279
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL2.5 mg
Inactive Ingredients
Ingredient NameStrength
CORN SYRUP 
SODIUM ACETATE 
SOYBEAN OIL 
SUCROSE 
Product Characteristics
ColorBROWNScoreno score
ShapeCAPSULESize22mm
FlavorMENTHOLImprint Code LUDENS
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52183-279-1414 in 1 CARTON
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35610/29/2009
LUDENS HONEY LICORICE THROAT DROPS 
menthol lozenge
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:52183-259
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL1.0 mg
Inactive Ingredients
Ingredient NameStrength
CORN SYRUP 
SODIUM ACETATE 
SOYBEAN OIL 
SUCROSE 
GLYCERIN 
HONEY 
Product Characteristics
ColorBLACKScoreno score
ShapeCAPSULESize22mm
FlavorLICORICEImprint Code LUDENS
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52183-259-1414 in 1 CARTON
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 DRUG LABELItem Code (Source)NDC:52183-269
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL1.0 mg
Inactive Ingredients
Ingredient NameStrength
CORN SYRUP 
SODIUM ACETATE 
SOYBEAN OIL 
SUCROSE 
HONEY 
ASCORBIC ACID 
CITRIC ACID MONOHYDRATE 
FD&C YELLOW NO. 5 
SODIUM CHLORIDE 
Product Characteristics
ColorYELLOWScoreno score
ShapeCAPSULESize22mm
FlavorLEMONImprint Code LUDENS
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52183-269-1414 in 1 CARTON
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35610/29/2009
LUDENS HONEY LICORICE THROAT DROPS 
menthol lozenge
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:52183-255
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL1.6 mg
Inactive Ingredients
Ingredient NameStrength
CORN SYRUP 
SODIUM ACETATE 
SOYBEAN OIL 
SUCROSE 
GLYCERIN 
HONEY 
Product Characteristics
ColorBLACKScoreno score
ShapeCAPSULESize22mm
FlavorLICORICEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52183-255-3030 in 1 BAG
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 DRUG LABELItem Code (Source)NDC:52183-266
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL1.6 mg
Inactive Ingredients
Ingredient NameStrength
CORN SYRUP 
SODIUM ACETATE 
SOYBEAN OIL 
SUCROSE 
HONEY 
ASCORBIC ACID 
CITRIC ACID MONOHYDRATE 
FD&C YELLOW NO. 5 
SODIUM CHLORIDE 
Product Characteristics
ColorYELLOWScoreno score
ShapeCAPSULESize22mm
FlavorLEMONImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52183-266-3030 in 1 BAG
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35610/29/2009
Labeler - Prestige Brands Holdings, Inc. (159655021)
Establishment
NameAddressID/FEIBusiness Operations
BestSweet Inc.002149136MANUFACTURE(52183-269, 52183-259, 52183-279, 52183-255, 52183-266)

Revised: 8/2012
 
Prestige Brands Holdings, Inc.

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