NDC | 52183-101-01, 52183-102-01, 52183-201-01, 52183-202-01, 52183-204-25, 52183-208-20, 52183-209-25, 52183-229-30, 52183-229-90, 52183-289-30, 52183-299-20 |
Set ID | adfb248a-96bb-4742-9df6-c47edccdd671 |
Category | HUMAN OTC DRUG LABEL |
Packager | Prestige Brands Holdings, Inc. |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART356 |
- 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?
- Principal Display Panel
- Principal Display Panel
- Principal Display Panel
- Principal Display Panel
- Principal Display Panel
- Principal Display Panel
- Principal Display Panel
- Principal Display Panel
- Principal Display Panel
- Principal Display Panel
-
INGREDIENTS AND APPEARANCE
LUDENS BLUE RASPBERRY THROAT DROPS
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 DROPS
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 DROPS
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 DROPS
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 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 DROPS
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 DROPS
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 DROPS
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 WILD CHERRY THROAT DROPS
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 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part356 10/29/2009 LUDENS BERRY ASSORTMENT THROAT DROPS
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 DROPS
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 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)