Label: LUDENS ORIGINAL MENTHOL THROAT DROPS- menthol lozenge
LUDENS HONEY LICORICE THROAT DROPS- menthol lozenge
LUDENS HONEY LEMON THROAT DROPS- menthol lozenge
-
NDC Code(s):
52183-255-30,
52183-259-14,
52183-259-20,
52183-266-30, view more52183-269-14, 52183-269-30, 52183-279-14
- 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 June 30, 2020
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
- 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
-
INGREDIENTS AND APPEARANCE
LUDENS ORIGINAL MENTHOL THROAT DROPS
menthol lozengeProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52183-279 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:52183-279-14 14 in 1 CARTON; Type 0: Not a Combination Product 10/29/2009 08/31/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part356 10/29/2009 08/31/2017 LUDENS HONEY LICORICE THROAT DROPS
menthol lozengeProduct 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:52183-259-14 14 in 1 CARTON; Type 0: Not a Combination Product 10/29/2009 2 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 lozengeProduct 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:52183-269-14 14 in 1 CARTON; Type 0: Not a Combination Product 10/29/2009 08/31/2021 2 NDC:52183-269-30 30 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 HONEY LICORICE THROAT DROPS
menthol lozengeProduct 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 lozengeProduct 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 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 Labeler - Prestige Brands Holdings, Inc. (159655021)