Label: LUDENS HONEY LEMON- pectin lozenge
- NDC Code(s): 52183-220-25, 52183-220-90
- 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 February 25, 2019
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient (in each drop)
- Purpose
- Uses
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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
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INGREDIENTS AND APPEARANCE
LUDENS HONEY LEMON
pectin lozengeProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52183-220 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 YELLOW NO. 5 (UNII: I753WB2F1M) HONEY (UNII: Y9H1V576FH) LEMON OIL (UNII: I9GRO824LL) SODIUM ACETATE (UNII: 4550K0SC9B) SODIUM CHLORIDE (UNII: 451W47IQ8X) SUCROSE (UNII: C151H8M554) WATER (UNII: 059QF0KO0R) Product Characteristics Color YELLOW Score no score Shape OVAL Size 23mm Flavor LEMON, HONEY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52183-220-25 25 in 1 BAG; Type 0: Not a Combination Product 02/01/2018 2 NDC:52183-220-90 90 in 1 BAG; Type 0: Not a Combination Product 02/01/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part356 02/01/2018 Labeler - Prestige Brands Holdings, Inc. (159655021)