Ludens Honey Lemon: Package Insert and Label Information

LUDENS HONEY LEMON- pectin lozenge
Prestige Brands Holdings, Inc.

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 Facts

Active ingredient (in each drop)

Pectin 2.8 mg

Purpose

Oral demulcent

Uses

for temporary relief of minor discomfort and protection of irritated areas in sore mouth and sore throat.

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.

Stop use and ask a doctor if

• sore mouth does not improve in 7 days
  
• irritation, pain or redness persists or worsens

Keep out of reach of children

Directions

• adults and children 3 years of age and older : allow one drop to dissolve slowly in mouth
  ▪ may be repeated as needed or as directed by a doctor
  
• children under 3 years of age : ask a doctor

Other information

• store at 20º-25ºC (68º-77ºF) in a dry place
  
• Contains FD&C yellow no. 5 (tartrazine) as a color additive

Inactive ingredients

ascorbic acid, citric acid, corn syrup, FD&C yellow no. 5, honey, lemon oil, sodium acetate, sodium chloride, sucrose, water

Questions?

1-866-583-3677 Ludens.com

P RINCIPAL D ISPLAY P ANEL

Luden’s _®

Honey Lemon

Pectin lozenge/ oral demulcent

25 Throat Drops

Luden’s _®

Honey Lemon

Pectin lozenge/ oral demulcent

90 Throat Drops

LUDENS HONEY LEMON pectin lozenge

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52183-220 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PECTIN (PECTIN) PECTIN 2.8 mg

Inactive Ingredients Ingredient Name Strength ASCORBIC ACID CITRIC ACID MONOHYDRATE CORN SYRUP FD&C YELLOW NO. 5 HONEY LEMON OIL SODIUM ACETATE SODIUM CHLORIDE SUCROSE WATER

Product Characteristics Color YELLOW Score no score Shape OVAL Size 23mm Flavor LEMON, HONEY Imprint Code Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:52183-220-25 25 LOZENGE in 1 BAG None 2 NDC:52183-220-90 90 LOZENGE in 1 BAG None

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)

Revised: 02/2019 Prestige Brands Holdings, Inc.