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NDC 52183-0289-30 Ludens Berry Assortment Throat Drops 2.8 mg/1 Details

Ludens Berry Assortment Throat Drops 2.8 mg/1

Ludens Berry Assortment Throat Drops is a ORAL LOZENGE in the HUMAN OTC DRUG category. It is labeled and distributed by Prestige Brands Holdings, Inc.. The primary component is PECTIN.

Product Information

NDC	52183-0289
Product ID	52183-289_558fe182-2401-4314-9e6f-ca6e644bb112
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Ludens Berry Assortment Throat Drops
Proprietary Name Suffix	n/a
Non-Proprietary Name	Pectin
Product Type	HUMAN OTC DRUG
Dosage Form	LOZENGE
Route	ORAL
Active Ingredient Strength	2.8
Active Ingredient Units	mg/1
Substance Name	PECTIN
Labeler Name	Prestige Brands Holdings, Inc.
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part356
Listing Certified Through	2024-12-31

Package

Package Images

NDC 52183-0289-30 (52183028930)

Pricing Information	N/A
NDC Package Code	52183-289-30
Billing NDC	52183028930
Package	30 LOZENGE in 1 BAG (52183-289-30)
Marketing Start Date	2009-10-29
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL adfb248a-96bb-4742-9df6-c47edccdd671 Details

SPL UNCLASSIFIED SECTION

Luden’s Blue Raspberry Throat Drops

Drug Facts

Active ingredient (in each drop)

Pectin 2.8 mg

Purpose

Oral demulcent

Uses

For temporary relief of minor discomfort and protection of irritated areas in 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.

Keep out of reach of children

Directions

Adults and children 3 years of age and older: allow one drop to dissolve slowly in mouth.
may be repeated as needed or as directed by a doctor.
children under 3 years of age: ask a doctor

Other information

store at 20º-25ºC (68º-77ºF) in a dry place

Questions?

1-866-583-3677 Ludens.com

Inactive ingredients

ascorbic acid, citric acid, corn syrup, FD&C blue no. 1, flavors, malic acid, sodium acetate, sodium chloride, soybean oil, sucrose, water

Luden’s Blue Raspberry Throat Drops

Drug Facts

Active ingredient (in each drop)

Pectin 1.7 mg

Purpose

Oral demulcent

Uses

For temporary relief of minor discomfort and protection of irritated areas in sore mouth and sore throat.

Warnings

Stop use and ask a doctor if

sore mouth does not improve in 7 days
irritation, pain or redness persists or worsens.

Keep out of reach of children

Directions

Adults and children 3 years of age and older: allow one drop to dissolve slowly in mouth.
may be repeated as needed or as directed by a doctor.
children under 3 years of age: ask a doctor

Other information

store at 20º-25ºC (68º-77ºF) in a dry place

Questions?

1-866-583-3677 Ludens.com

Inactive ingredients

ascorbic acid, citric acid, corn syrup, FD&C blue no. 1, flavors, malic acid, sodium acetate, sodium chloride, soybean oil, sucrose, water

Luden’s Watermelon Throat Drops

Drug Facts

Active ingredient (in each drop)

Pectin 2.8 mg

Purpose

Oral demulcent

Uses

For temporary relief of minor discomfort and protection of irritated areas in sore mouth and sore throat.

Warnings

Stop use and ask a doctor if

sore mouth does not improve in 7 days
irritation, pain or redness persists or worsens.

Keep out of reach of children

Directions

Adults and children 3 years of age and older: allow one drop to dissolve slowly in mouth.
may be repeated as needed or as directed by a doctor.
children under 3 years of age: ask a doctor

Other information

store at 20º-25ºC (68º-77ºF) in a dry place

Questions?

1-866-583-3677 Ludens.com

Inactive ingredients

ascorbic acid, citric acid, corn syrup, FD&C red no. 40, flavors, malic acid, sodium acetate, sodium chloride, soybean oil, sucrose, water

Luden’s Watermelon Throat Drops

Drug Facts

Active ingredient (in each drop)

Pectin 1.7 mg

Purpose

Oral demulcent

Uses

For temporary relief of minor discomfort and protection of irritated areas in sore mouth and sore throat.

Warnings

Stop use and ask a doctor if

sore mouth does not improve in 7 days
irritation, pain or redness persists or worsens.

Keep out of reach of children

Directions

Adults and children 3 years of age and older: allow one drop to dissolve slowly in mouth.
may be repeated as needed or as directed by a doctor.
children under 3 years of age: ask a doctor

Other information

store at 20º-25ºC (68º-77ºF) in a dry place

Questions?

1-866-583-3677 Ludens.com

Inactive ingredients

ascorbic acid, citric acid, corn syrup, FD&C red no. 40, flavors, malic acid, sodium acetate, sodium chloride, soybean oil, sucrose, water

Luden’s Wild Berry Throat Drops

Drug Facts

Active ingredient (in each drop)

Pectin 2.8 mg

Purpose

Oral demulcent

Uses

for temporary relief of minor discomfort and protection of irritated areas in sore mouth and sore throat.

Warnings

Stop use and ask a doctor if

sore mouth does not improve in 7 days
irritation, pain or redness persists or worsens.

Keep out of reach of children

Directions

Adults and children 3 years of age and older: allow one drop to dissolve slowly in mouth.
may be repeated as needed or as directed by a doctor.
children under 3 years of age: ask a doctor

Other information

store at 68º-77ºF (20º-25ºC) in a dry place

Questions?

1-866-583-3677 Ludens.com

Inactive ingredients

ascorbic acid, citric acid, corn syrup, FD&C blue 1, FD&C blue 2, FD&C red 40, flavors, malic acid, sodium acetate, sodium chloride, soybean oil, and sucrose.

Luden’s Wild Cherry Throat Drops

Drug Facts

Active ingredient (in each drop)

Pectin 1.7 mg

Purpose

Oral demulcent

Uses

for temporary relief of minor discomfort and protection of irritated areas in sore mouth and sore throat.

Warnings

Stop use and ask a doctor if

sore mouth does not improve in 7 days
irritation, pain or redness persists or worsens

Keep out of reach of children.

Directions

adults and children 3 years of age and older: allow one drop to dissolve slowly in mouth.
may be repeated as needed or as directed by a doctor
children under 3 years of age: ask a doctor

Other information

store at 20-25ºC (68º-77ºF) in a dry place
do not use if clear outer wrap is opened or missing.

Inactive ingredients

Ascorbic Acid, Citric Acid, Corn Syrup, FD&C Blue No. 2, FD&C Red No. 40, Flavors, Malic Acid, Sodium Acetate, Sodium Chloride, Soybean Oil used as a processing aid, Sucrose, Water

Questions or comments?

call 1-866-583-3677

Luden’s Wild Cherry Throat Drops

Drug Facts

Active ingredient (in each drop)

Pectin 2.8 mg

Purpose

Oral demulcent

Uses

for temporary relief of minor discomfort and protection of irritated areas in sore mouth and sore throat

Warnings

Stop use and ask a doctor if

sore mouth does not improve in 7 days
irritation, pain or redness persists or worsens

Keep out of reach of children.

Directions

adults and children 3 years of age and older: allow one drop to dissolve slowly in mouth.
may be repeated as needed 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

ascorbic acid, citric acid, corn syrup, FD&C blue no. 2, FD&C red no. 40, flavors, malic acid, sodium acetate, sodium chloride, soybean oil (processing aid), sucrose, water

Questions or comments?

call 1-866-583-3677

Luden's Strawberry Banana Throat Drops

Drug Facts

Active ingredient (in each drop)

Pectin 1.7 mg

Purpose

Oral demulcent

Uses

For temporary relief of minor discomfort and protection of irritated areas in sore mouth and sore throat.

Warnings

Stop use and ask a doctor if

• sore mouth does not improve in 7 days

• irritation, pain or redness persists or worsens

Keep out of reach of children

Directions

• adults and children 3 years of age and older: allow one drop to dissolve slowly in mouth

• may be repeated as needed or as directed by a doctor

• children under 3 years of age: ask a doctor

Other information

• store at 20º-25ºC (68º-77ºF) in a dry place

• do not use if clear outer wrap is opened or missing

Inactive ingredients

citric acid, corn syrup, FD&C blue no. 2, FD&C red no. 40, FD&C yellow no. 6, flavors, malic acid, sodium acetate, sodium chloride, soybean oil, sucrose, water

Questions?

1-866-583-3677 Ludens.com

Luden's Strawberry Banana Throat Drops

Drug Facts

Active ingredient (in each drop)

Pectin 2.8 mg

Purpose

Oral demulcent

Uses

For temporary relief of minor discomfort and protection of irritated areas in sore mouth and sore throat.

Warnings

Stop use and ask a doctor if

• sore mouth does not improve in 7 days

• irritation, pain or redness persists or worsens

Keep out of reach of children

Directions

• adults and children 3 years of age and older: allow one drop to dissolve slowly in mouth

• may be repeated as needed or as directed by a doctor

• children under 3 years of age: ask a doctor

Other information

• store at 20º-25ºC (68º-77ºF) in a dry place

• do not use if clear outer wrap is opened or missing

Inactive ingredients

citric acid, corn syrup, FD&C blue no. 2, FD&C red no. 40, FD&C yellow no. 6, flavors, malic acid, sodium acetate, sodium chloride, soybean oil, sucrose, water

Questions?

1-866-583-3677 Ludens.com

Luden's Green Apple Throat Drops

Drug Facts

Active ingredient (in each drop)

Pectin 2.8 mg

Purpose

Oral demulcent

Uses

For temporary relief of minor discomfort and protection of irritated areas in sore mouth and sore throat.

Warnings

Stop use and ask a doctor if

• sore mouth does not improve in 7 days

• irritation, pain or redness persists or worsens

Keep out of reach of children

Directions

• adults and children 3 years of age and older: allow one drop to dissolve slowly in mouth

• may be repeated as needed or as directed by a doctor

• children under 3 years of age: ask a doctor

Other information

• store at 20º-25ºC (68º-77ºF) in a dry place

• contains FD&C Yellow No. 5 (tartrazine)as a color additive

Inactive ingredients

citric acid, corn syrup, FD&C Blue No. 1, FD&C Yellow No. 5, flavor, malic acid, sodium acetate, sodium choride, sucrose, water

Questions?

1-866-583-3677 Ludens.com

Principal Display Panel

Luden’s

Pectin Lozenge/Oral Demulcent

Blue Raspberry

25 Throat Drops

Principal Display Panel

Luden’s

Pectin Lozenge/Oral Demulcent

Blue Raspberry

20 Throat Drops

Principal Display Panel

Luden’s

Pectin Lozenge/Oral Demulcent

Watermelon

25 Throat Drops

Principal Display Panel

Luden’s

Pectin Lozenge/Oral Demulcent

Watermelon

20 Throat Drops

Principal Display Panel

Luden’s

Pectin Lozenge/Oral Demulcent

Watermelon

90 Throat Drops

Principal Display Panel

Luden’s

Pectin Lozenge/Oral Demulcent

Wild Berry

30 Drops

Principal Display Panel

Luden’s

Pectin Lozenge

Oral Demulcent

Wild Cherry

14 Drops

Principal Display Panel

Luden’s

Pectin Lozenge/Oral Demulcent

Wild Cherry

30 Drops

Principal Display Panel

Luden’s Strawberry-Banana

Pectin lozenge / Oral Demulcent

20 Throat drops

Principal Display Panel

Luden’s Strawberry-Banana

Pectin lozenge / Oral Demulcent

25 Throat drops

Principal Display Panel

Luden’s Green Apple

Pectin lozenge / Oral Demulcent

25 Throat drops

INGREDIENTS AND APPEARANCE

LUDENS BERRY ASSORTMENT THROAT DROPS

pectin lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:52183-289
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PECTIN (UNII: 89NA02M4RX) (PECTIN - UNII:89NA02M4RX)	PECTIN	2.8 mg

Ingredient Name	Strength
Inactive Ingredients
ASCORBIC ACID (UNII: PQ6CK8PD0R)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
CORN SYRUP (UNII: 9G5L16BK6N)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
FD&C RED NO. 40 (UNII: WZB9127XOA)
MALIC ACID (UNII: 817L1N4CKP)
SODIUM ACETATE (UNII: 4550K0SC9B)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SOYBEAN OIL (UNII: 241ATL177A)
SUCROSE (UNII: C151H8M554)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:52183-289-30	30 in 1 BAG; Type 0: Not a Combination Product	10/29/2009

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

LUDENS WILD CHERRY THROAT DROPS

pectin lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:52183-299
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PECTIN (UNII: 89NA02M4RX) (PECTIN - UNII:89NA02M4RX)	PECTIN	1.7 mg

Ingredient Name	Strength
Inactive Ingredients
ASCORBIC ACID (UNII: PQ6CK8PD0R)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
CORN SYRUP (UNII: 9G5L16BK6N)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
FD&C RED NO. 40 (UNII: WZB9127XOA)
MALIC ACID (UNII: 817L1N4CKP)
SODIUM ACETATE (UNII: 4550K0SC9B)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SOYBEAN OIL (UNII: 241ATL177A)
SUCROSE (UNII: C151H8M554)

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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:52183-299-14	14 in 1 CARTON; Type 0: Not a Combination Product	10/29/2009
2	NDC:52183-299-20	20 in 1 BOX; Type 0: Not a Combination Product	10/29/2009

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

LUDENS WILD CHERRY THROAT DROPS

pectin lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:52183-229
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PECTIN (UNII: 89NA02M4RX) (PECTIN - UNII:89NA02M4RX)	PECTIN	2.8 mg

Ingredient Name	Strength
Inactive Ingredients
ASCORBIC ACID (UNII: PQ6CK8PD0R)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
CORN SYRUP (UNII: 9G5L16BK6N)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
FD&C RED NO. 40 (UNII: WZB9127XOA)
MALIC ACID (UNII: 817L1N4CKP)
SODIUM ACETATE (UNII: 4550K0SC9B)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SOYBEAN OIL (UNII: 241ATL177A)
SUCROSE (UNII: C151H8M554)

Product Characteristics
Color	red	Score	no score
Shape	CAPSULE	Size	22mm
Flavor	CHERRY	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:52183-229-30	30 in 1 BAG; Type 0: Not a Combination Product	10/29/2009
2	NDC:52183-229-90	90 in 1 BAG; Type 0: Not a Combination Product	10/29/2009

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

LUDENS STRAWBERRY BANANA THROAT DROPS

pectin lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:52183-208
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PECTIN (UNII: 89NA02M4RX) (PECTIN - UNII:89NA02M4RX)	PECTIN	1.7 mg

Ingredient Name	Strength
Inactive Ingredients
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
CORN SYRUP (UNII: 9G5L16BK6N)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
MALIC ACID (UNII: 817L1N4CKP)
SODIUM ACETATE (UNII: 4550K0SC9B)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SOYBEAN OIL (UNII: 241ATL177A)
SUCROSE (UNII: C151H8M554)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	red	Score	no score
Shape	OVAL	Size	21mm
Flavor	STRAWBERRY (Strawberry Banana) , BANANA (Strawberry Banana)	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:52183-208-20	20 in 1 CARTON; Type 0: Not a Combination Product	07/01/2015	08/31/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part356	07/01/2015	08/31/2021

LUDENS STRAWBERRY BANANA THROAT DROPS

pectin lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:52183-209
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PECTIN (UNII: 89NA02M4RX) (PECTIN - UNII:89NA02M4RX)	PECTIN	2.8 mg

Ingredient Name	Strength
Inactive Ingredients
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
CORN SYRUP (UNII: 9G5L16BK6N)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
MALIC ACID (UNII: 817L1N4CKP)
SODIUM ACETATE (UNII: 4550K0SC9B)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SOYBEAN OIL (UNII: 241ATL177A)
SUCROSE (UNII: C151H8M554)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	red	Score	no score
Shape	OVAL	Size	23mm
Flavor	STRAWBERRY (Strawberry Banana) , BANANA (Strawberry Banana)	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:52183-209-25	25 in 1 BAG; Type 0: Not a Combination Product	07/01/2015

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part356	07/01/2015

LUDENS GREEN APPLE THROAT DROPS

pectin lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:52183-204
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PECTIN (UNII: 89NA02M4RX) (PECTIN - UNII:89NA02M4RX)	PECTIN	2.8 mg

Ingredient Name	Strength
Inactive Ingredients
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
CORN SYRUP (UNII: 9G5L16BK6N)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
MALIC ACID (UNII: 817L1N4CKP)
SODIUM ACETATE (UNII: 4550K0SC9B)
SUCROSE (UNII: C151H8M554)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	green	Score	no score
Shape	CAPSULE	Size	23mm
Flavor	APPLE (Green Apple)	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:52183-204-25	25 in 1 BAG; Type 0: Not a Combination Product	08/01/2015

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part356	08/01/2015

LUDENS BLUE RASPBERRY THROAT DROPS

pectin lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:52183-101
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PECTIN (UNII: 89NA02M4RX) (PECTIN - UNII:89NA02M4RX)	PECTIN	1.7 mg

Ingredient Name	Strength
Inactive Ingredients
ASCORBIC ACID (UNII: PQ6CK8PD0R)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
CORN SYRUP (UNII: 9G5L16BK6N)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
MALIC ACID (UNII: 817L1N4CKP)
SODIUM ACETATE (UNII: 4550K0SC9B)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SOYBEAN OIL (UNII: 241ATL177A)
SUCROSE (UNII: C151H8M554)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	blue	Score	no score
Shape	OVAL	Size	21mm
Flavor	RASPBERRY (Blue Raspberry)	Imprint Code	ludens
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:52183-101-01	20 in 1 CARTON; Type 0: Not a Combination Product	10/29/2009	08/31/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part356	10/29/2009	08/31/2021

LUDENS BLUE RASPBERRY THROAT DROPS

pectin lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:52183-201
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PECTIN (UNII: 89NA02M4RX) (PECTIN - UNII:89NA02M4RX)	PECTIN	2.8 mg

Ingredient Name	Strength
Inactive Ingredients
ASCORBIC ACID (UNII: PQ6CK8PD0R)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
CORN SYRUP (UNII: 9G5L16BK6N)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
MALIC ACID (UNII: 817L1N4CKP)
SODIUM ACETATE (UNII: 4550K0SC9B)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SOYBEAN OIL (UNII: 241ATL177A)
SUCROSE (UNII: C151H8M554)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	blue	Score	no score
Shape	OVAL	Size	23mm
Flavor	RASPBERRY (Blue Raspberry)	Imprint Code	ludens
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:52183-201-01	25 in 1 BAG; Type 0: Not a Combination Product	10/29/2009	08/31/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part356	10/29/2009	08/31/2021

LUDENS WATERMELON THROAT DROPS

pectin lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:52183-102
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PECTIN (UNII: 89NA02M4RX) (PECTIN - UNII:89NA02M4RX)	PECTIN	1.7 mg

Ingredient Name	Strength
Inactive Ingredients
ASCORBIC ACID (UNII: PQ6CK8PD0R)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
CORN SYRUP (UNII: 9G5L16BK6N)
FD&C RED NO. 40 (UNII: WZB9127XOA)
MALIC ACID (UNII: 817L1N4CKP)
SODIUM ACETATE (UNII: 4550K0SC9B)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SOYBEAN OIL (UNII: 241ATL177A)
SUCROSE (UNII: C151H8M554)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	red (light red)	Score	no score
Shape	OVAL	Size	21mm
Flavor	WATERMELON	Imprint Code	ludens
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:52183-102-01	20 in 1 CARTON; Type 0: Not a Combination Product	10/29/2009

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

LUDENS WATERMELON THROAT DROPS

pectin lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:52183-202
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PECTIN (UNII: 89NA02M4RX) (PECTIN - UNII:89NA02M4RX)	PECTIN	2.8 mg

Ingredient Name	Strength
Inactive Ingredients
ASCORBIC ACID (UNII: PQ6CK8PD0R)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
CORN SYRUP (UNII: 9G5L16BK6N)
FD&C RED NO. 40 (UNII: WZB9127XOA)
MALIC ACID (UNII: 817L1N4CKP)
SODIUM ACETATE (UNII: 4550K0SC9B)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SOYBEAN OIL (UNII: 241ATL177A)
SUCROSE (UNII: C151H8M554)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	red	Score	no score
Shape	OVAL	Size	23mm
Flavor	WATERMELON	Imprint Code	ludens
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:52183-202-01	25 in 1 CARTON; Type 0: Not a Combination Product	10/29/2009
2	NDC:52183-202-90	90 in 1 BAG; Type 0: Not a Combination Product	10/29/2009

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

Labeler - Prestige Brands Holdings, Inc. (159655021)

Revised: 12/2021

Document Id: 558fe182-2401-4314-9e6f-ca6e644bb112

Set id: adfb248a-96bb-4742-9df6-c47edccdd671

Version: 11

Effective Time: 20211221

Search by Drug Name or NDC

NDC 52183-0289-30 Ludens Berry Assortment Throat Drops 2.8 mg/1 Details

Ludens Berry Assortment Throat Drops 2.8 mg/1

Product Information

Package

Package Images

NDC 52183-0289-30 (52183028930)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL adfb248a-96bb-4742-9df6-c47edccdd671 Details

SPL UNCLASSIFIED SECTION

Active ingredient (in each drop)

Purpose

Uses

Warnings

Stop use and ask a doctor if

Keep out of reach of children

Directions

Other information

Questions?

Inactive ingredients

Active ingredient (in each drop)

Purpose

Uses

Warnings

Stop use and ask a doctor if

Keep out of reach of children

Directions

Other information

Questions?

Inactive ingredients

Active ingredient (in each drop)

Purpose

Uses

Warnings

Stop use and ask a doctor if

Keep out of reach of children

Directions

Other information

Questions?

Inactive ingredients

Active ingredient (in each drop)

Purpose

Uses

Warnings

Stop use and ask a doctor if

Keep out of reach of children

Directions

Other information

Questions?

Inactive ingredients

Active ingredient (in each drop)

Purpose

Uses

Warnings

Stop use and ask a doctor if

Keep out of reach of children

Directions

Other information

Questions?

Inactive ingredients

Active ingredient (in each drop)

Purpose

Uses

Warnings

Stop use and ask a doctor if

Keep out of reach of children.

Directions

Other information

Inactive ingredients

Questions or comments?

Active ingredient (in each drop)

Purpose

Uses

Warnings

Stop use and ask a doctor if

Keep out of reach of children.

Directions

Other information

Inactive ingredients

Questions or comments?