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

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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

 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 health professional 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

Inactive ingredients

caramel color, corn syrup, flavors, sodium acetate, soybean oil, and sucrose

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 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
  

Inactive ingredients

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

Questions or comments?

call 1-866-583-3677 

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 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

ascorbic acid, citric acid, corn syrup, FD&C yellow no. 5, flavors, honey, sodium acetate, sodium chloride, soybean oil, and sucrose

Questions or comments?

call 1-866-583-3677

Principal Display Panel 

Luden’s 
Great Tasting
Original Menthol
Throat Drops
Menthol lozenge/ Oral Anesthetic
Soothes Everyday Throat Irritation 14 Drops

Principal Display Panel

Luden’s 
Great Tasting
Honey Licorice
Throat Drops
Menthol Lozenge/ Oral anesthetic
Soothes Everyday Throat Irritation 14 Drops

Principal Display Panel

Luden’s 
Great Tasting
Honey Lemon
Throat Drops
Menthol Lozenge/ Oral anesthetic
Soothes Everyday Throat Irritation 14 Drops

LUDENS ORIGINAL MENTHOL THROAT DROPS  menthol   lozenge

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 52183-279 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (MENTHOL) MENTHOL 2.5 mg

Inactive Ingredients Ingredient Name Strength CORN SYRUP   SODIUM ACETATE   SOYBEAN OIL   SUCROSE

Product Characteristics Color BROWN Score no score Shape CAPSULE Size 22mm Flavor MENTHOL Imprint Code LUDENS Contains

Packaging # NDC Package Description Multilevel Packaging 1 52183-279-14 14 LOZENGE In 1 CARTON None

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 NDC Product Code (Source) 52183-259 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (MENTHOL) MENTHOL 1.0 mg

Inactive Ingredients Ingredient Name Strength CORN SYRUP   SODIUM ACETATE   SOYBEAN OIL   SUCROSE   GLYCERIN   HONEY

Product Characteristics Color BLACK Score no score Shape CAPSULE Size 22mm Flavor LICORICE Imprint Code LUDENS Contains

Packaging # NDC Package Description Multilevel Packaging 1 52183-259-14 14 LOZENGE In 1 CARTON None 2 52183-259-30 30 LOZENGE In 1 BAG None

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 NDC Product Code (Source) 52183-269 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (MENTHOL) MENTHOL 1.0 mg

Inactive Ingredients Ingredient Name Strength CORN SYRUP   SODIUM ACETATE   SOYBEAN OIL   SUCROSE   HONEY   ASCORBIC ACID   CITRIC ACID   FD&C YELLOW NO. 5   SODIUM CHLORIDE

Product Characteristics Color YELLOW Score no score Shape CAPSULE Size 22mm Flavor LEMON Imprint Code LUDENS Contains

Packaging # NDC Package Description Multilevel Packaging 1 52183-269-14 14 LOZENGE In 1 CARTON None 2 52183-269-30 30 LOZENGE In 1 BAG None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part356	10/29/2009

Labeler - Blacksmith Brands, Inc. (021411299)

Establishment
Name	Address	ID/FEI	Operations
BestSweet Inc.		002149136	MANUFACTURE

Revised: 03/2010Blacksmith Brands, Inc.