Label: LUDENS SUGAR FREE WILD CHERRY THROAT- pectin lozenge
- NDC Code(s): 52183-249-18, 52183-249-25, 52183-249-75
- 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 25, 2020
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- SPL UNCLASSIFIED SECTION
- Active ingredient
- 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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INGREDIENTS AND APPEARANCE
LUDENS SUGAR FREE WILD CHERRY THROAT
pectin lozengeProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52183-249 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 ACESULFAME POTASSIUM (UNII: 23OV73Q5G9) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) FD&C BLUE NO. 2 (UNII: L06K8R7DQK) FD&C RED NO. 40 (UNII: WZB9127XOA) HYDROGENATED STARCH HYDROLYSATE (UNII: 27F77DSJ5V) ISOMALT (UNII: S870P55O2W) MALIC ACID (UNII: 817L1N4CKP) SOYBEAN OIL (UNII: 241ATL177A) WATER (UNII: 059QF0KO0R) Product Characteristics Color RED Score no score Shape OVAL Size 22mm Flavor Imprint Code LUDENS Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52183-249-18 18 in 1 BAG; Type 0: Not a Combination Product 07/12/2010 2 NDC:52183-249-25 25 in 1 BAG; Type 0: Not a Combination Product 07/12/2010 3 NDC:52183-249-75 75 in 1 BAG; Type 0: Not a Combination Product 07/12/2010 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part356 07/12/2010 Labeler - Prestige Brands Holdings, Inc. (159655021)