Label: LUDENS ASSORTED FLAVORS- pectin lozenge
- NDC Code(s): 52183-217-90
- 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 April 2, 2018
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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
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Inactive ingredients
Wild Cherry: ascorbic acid, citric acid, corn syrup, FD&C blue no. 2, FD&C red no. 40, flavors, malic acid, sodium acetate, sodium chloride, soybean oil, sucrose, water
Watermelon: ascorbic acid, citric acid, corn syrup, FD&C red no. 40, flavors, malic acid, sodium acetate, sodium chloride, soybean oil, sucrose, water
Honey & Berry: caramel color, citric acid, corn syrup, FD&C blue no. 1, FD&C red no. 40, flavor, honey, sodium acetate, sodium chloride, soybean oil, sucrose, water
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INGREDIENTS AND APPEARANCE
LUDENS ASSORTED FLAVORS
pectin lozengeProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52183-217 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) WATER (UNII: 059QF0KO0R) CARAMEL (UNII: T9D99G2B1R) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) HONEY (UNII: Y9H1V576FH) Product Characteristics Color RED, YELLOW Score no score Shape OVAL Size 23mm Flavor FRUIT (Wild cherry, watermelon, honey & berry) Imprint Code LUDENS Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52183-217-90 90 in 1 BAG; Type 0: Not a Combination Product 06/13/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part356 06/13/2017 Labeler - Prestige Brands Holdings, Inc. (159655021)