Label: LUDENS BERRY ASSORTMENT THROAT DROPS- pectin lozenge
LUDENS WILD CHERRY THROAT DROPS- pectin lozenge
LUDENS STRAWBERRY BANANA THROAT DROPS- pectin lozenge
LUDENS GREEN APPLE THROAT DROPS- pectin lozenge
LUDENS BLUE RASPBERRY THROAT DROPS- pectin lozenge
LUDENS WATERMELON THROAT DROPS- pectin lozenge
-
NDC Code(s):
52183-101-01,
52183-102-01,
52183-201-01,
52183-202-01, view more52183-202-90, 52183-204-25, 52183-208-20, 52183-209-25, 52183-229-30, 52183-229-90, 52183-289-30, 52183-299-14, 52183-299-20
- Packager: Prestige Brands Holdings, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated December 21, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient (in each drop)
- Purpose
- 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.
- Directions
- Other information
- Questions?
- Inactive ingredients
- Active ingredient (in each drop)
- Purpose
- 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.
- Directions
- Other information
- Questions?
- Inactive ingredients
- Active ingredient (in each drop)
- Purpose
- 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.
- Directions
- Other information
- Questions?
- Inactive ingredients
- Active ingredient (in each drop)
- Purpose
- 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.
- Directions
- Other information
- Questions?
- Inactive ingredients
- Active ingredient (in each drop)
- Purpose
- 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.
- Directions
- Other information
- Questions?
- Inactive ingredients
- Active ingredient (in each drop)
- Purpose
- 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.
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
- Active ingredient (in each drop)
- Purpose
- 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.
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
- Active ingredient (in each drop)
- Purpose
- 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.
- Directions
- Other information
- Inactive ingredients
- Questions?
- Active ingredient (in each drop)
- Purpose
- 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.
- Directions
- Other information
- Inactive ingredients
- Questions?
- Active ingredient (in each drop)
- Purpose
- 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.
- Directions
- Other information
- Inactive ingredients
- Questions?
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INGREDIENTS AND APPEARANCE
LUDENS BERRY ASSORTMENT THROAT DROPSÂ
pectin lozengeProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52183-289 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PECTIN (UNII: 89NA02M4RX) (PECTIN - UNII:89NA02M4RX) PECTIN 2.8 mg Inactive Ingredients Ingredient Name Strength 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     Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52183-289-30 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 WILD CHERRY THROAT DROPSÂ
pectin lozengeProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52183-299 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PECTIN (UNII: 89NA02M4RX) (PECTIN - UNII:89NA02M4RX) PECTIN 1.7 mg Inactive Ingredients Ingredient Name Strength 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     Packaging # Item Code Package Description Marketing Start Date Marketing End Date 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 Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 10/29/2009 LUDENS WILD CHERRY THROAT DROPSÂ
pectin lozengeProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52183-229 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PECTIN (UNII: 89NA02M4RX) (PECTIN - UNII:89NA02M4RX) PECTIN 2.8 mg Inactive Ingredients Ingredient Name Strength 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     Packaging # Item Code Package Description Marketing Start Date Marketing End Date 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 Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 10/29/2009 LUDENS STRAWBERRY BANANA THROAT DROPSÂ
pectin lozengeProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52183-208 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PECTIN (UNII: 89NA02M4RX) (PECTIN - UNII:89NA02M4RX) PECTIN 1.7 mg Inactive Ingredients Ingredient Name Strength 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     Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52183-208-20 20 in 1 CARTON; Type 0: Not a Combination Product 07/01/2015 08/31/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 07/01/2015 08/31/2021 LUDENS STRAWBERRY BANANA THROAT DROPSÂ
pectin lozengeProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52183-209 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PECTIN (UNII: 89NA02M4RX) (PECTIN - UNII:89NA02M4RX) PECTIN 2.8 mg Inactive Ingredients Ingredient Name Strength 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     Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52183-209-25 25 in 1 BAG; Type 0: Not a Combination Product 07/01/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 07/01/2015 LUDENS GREEN APPLE THROAT DROPSÂ
pectin lozengeProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52183-204 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PECTIN (UNII: 89NA02M4RX) (PECTIN - UNII:89NA02M4RX) PECTIN 2.8 mg Inactive Ingredients Ingredient Name Strength 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     Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52183-204-25 25 in 1 BAG; Type 0: Not a Combination Product 08/01/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 08/01/2015 LUDENS BLUE RASPBERRY THROAT DROPSÂ
pectin lozengeProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52183-101 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PECTIN (UNII: 89NA02M4RX) (PECTIN - UNII:89NA02M4RX) PECTIN 1.7 mg Inactive Ingredients Ingredient Name Strength 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     Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52183-101-01 20 in 1 CARTON; Type 0: Not a Combination Product 10/29/2009 08/31/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 10/29/2009 08/31/2021 LUDENS BLUE RASPBERRY THROAT DROPSÂ
pectin lozengeProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52183-201 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PECTIN (UNII: 89NA02M4RX) (PECTIN - UNII:89NA02M4RX) PECTIN 2.8 mg Inactive Ingredients Ingredient Name Strength 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     Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52183-201-01 25 in 1 BAG; Type 0: Not a Combination Product 10/29/2009 08/31/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 10/29/2009 08/31/2021 LUDENS WATERMELON THROAT DROPSÂ
pectin lozengeProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52183-102 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PECTIN (UNII: 89NA02M4RX) (PECTIN - UNII:89NA02M4RX) PECTIN 1.7 mg Inactive Ingredients Ingredient Name Strength 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     Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52183-102-01 20 in 1 CARTON; 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 WATERMELON THROAT DROPSÂ
pectin lozengeProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52183-202 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PECTIN (UNII: 89NA02M4RX) (PECTIN - UNII:89NA02M4RX) PECTIN 2.8 mg Inactive Ingredients Ingredient Name Strength 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     Packaging # Item Code Package Description Marketing Start Date Marketing End Date 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 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)