LUDENS MENTHOL THROAT DROPS- menthol lozenge LUDENS HONEY LICORICE THROAT DROPS- menthol lozenge LUDENS HONEY LEMON THROAT DROPS- menthol lozenge

Ludens Honey Lemon Throat Drops by

Drug Labeling and Warnings

Ludens Honey Lemon Throat Drops by is a Otc medication manufactured, distributed, or labeled by Prestige Brands Holdings, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Luden's Menthol Throat Drops, 2.5 mg

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, glycerin, honey, sodium acetate, soybean oil used as a processing aid, sucrose, water

Questions?

1-866-583-3677  Ludens.com

Luden's Honey Licorice Throat Drops, 1 mg

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, 1.6 mg

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 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

Inactive ingredients

caramel color, corn syrup, flavors, glycerin, honey, sodium acetate, soybean oil used as a processing aid, sucrose

Questions?

1-866-583-3677 Ludens.com

Luden’s Honey Lemon Throat Drops, 1 mg

Drug Facts

Active ingredients

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 as a processing aid, sucrose

Questions?

1-866-583-3677  Ludens.com

Luden’s Honey Lemon Throat Drops, 1.6 mg

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.
• allow1 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 5, flavors, honey, sodium acetate, sodium chloride, soybean oil as a processing aid, sucrose

Questions?

1-866-583-3677  Ludens.com

PRINCIPAL DISPLAY PANEL

Luden's Menthol Sore Throat Drops, Menthol Oral Anesthetic

20 drops

PRINCIPAL DISPLAY PANEL

Luden's Honey Licorice Sore Throat Drops, Menthol Oral Anesthetic

20 drops

PRINCIPAL DISPLAY PANEL

Luden's Honey Licorice Sore Throat Drops, Menthol Oral Anesthetic

30 drops

PRINCIPAL DISPLAY PANEL

Luden's Honey Lemon Sore Throat Drops, Menthol Oral Anesthetic

20 drops

PRINCIPAL DISPLAY PANEL

Luden's Honey Lemon Sore Throat Drops, Menthol Oral Anesthetic

30 drops

INGREDIENTS AND APPEARANCE

LUDENS MENTHOL THROAT DROPS 
menthol lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52183-278
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	2.5 mg

Inactive Ingredients
Ingredient Name	Strength
CORN SYRUP (UNII: 9G5L16BK6N)
SODIUM ACETATE (UNII: 4550K0SC9B)
SOYBEAN OIL (UNII: 241ATL177A)
SUCROSE (UNII: C151H8M554)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52183-278-20	20 in 1 BOX; Type 0: Not a Combination Product	02/04/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	02/04/2014

LUDENS HONEY LICORICE THROAT DROPS 
menthol lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52183-259
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	1.0 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	black	Score	no score
Shape	capsule	Size	21mm
Flavor	LICORICE	Imprint Code	LUDENS
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52183-259-20	20 in 1 BOX; Type 0: Not a Combination Product	10/29/2009

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	Item Code (Source)	NDC: 52183-269
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	1.0 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	yellow	Score	no score
Shape	capsule	Size	23mm
Flavor	LEMON (Honey Lemon)	Imprint Code	LUDENS
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52183-269-20	20 in 1 BOX; Type 0: Not a Combination Product	02/04/2014

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	Item Code (Source)	NDC: 52183-255
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	1.6 mg

Inactive Ingredients
Ingredient Name	Strength
CORN SYRUP (UNII: 9G5L16BK6N)
SODIUM ACETATE (UNII: 4550K0SC9B)
SOYBEAN OIL (UNII: 241ATL177A)
SUCROSE (UNII: C151H8M554)
GLYCERIN (UNII: PDC6A3C0OX)
HONEY (UNII: Y9H1V576FH)

Product Characteristics
Color	black	Score	no score
Shape	capsule	Size	22mm
Flavor	LICORICE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52183-255-30	30 in 1 BAG; Type 0: Not a Combination Product	10/29/2009

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	Item Code (Source)	NDC: 52183-266
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	1.6 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	yellow	Score	no score
Shape	capsule	Size	22mm
Flavor	LEMON	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52183-266-30	30 in 1 BAG; Type 0: Not a Combination Product	10/29/2009

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	10/29/2009

Labeler - Prestige Brands Holdings, Inc. (159655021)

Establishment
Name	Address	ID/FEI	Business Operations
BestCo, Inc.		002149136	manufacture(52183-278, 52183-259, 52183-269, 52183-255, 52183-266)