Label: LUDENS HONEY AND BERRY- pectin lozenge
- NDC Code(s): 52183-212-25
- 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 May 31, 2017
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- 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
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- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
LUDENS HONEY AND BERRY
pectin lozengeProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52183-212 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 CARAMEL (UNII: T9D99G2B1R) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) CORN SYRUP (UNII: 9G5L16BK6N) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 40 (UNII: WZB9127XOA) 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, PURPLE Score no score Shape CAPSULE Size 22mm Flavor BLACKBERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52183-212-25 25 in 1 BAG; Type 0: Not a Combination Product 07/01/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part356 07/01/2017 Labeler - Prestige Brands Holdings, Inc. (159655021)