Ludens Honey and Berry: Package Insert and Label Information

LUDENS HONEY AND BERRY- 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

A ctive 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 20-25C (68-77F) in a dry place

Inactive ingredients

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

Questions?

1-866-583-3677 Ludens.com

PRINCIPAL DISPLAY PANEL

Luden’s

Pectin lozenge/ Oral demulcent
Honey & Berry
25 Throat Count

LUDENS HONEY AND BERRY pectin lozenge

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52183-212 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 CARAMEL CITRIC ACID MONOHYDRATE CORN SYRUP FD&C BLUE NO. 1 FD&C RED NO. 40 HONEY SODIUM ACETATE SODIUM CHLORIDE SOYBEAN OIL SUCROSE WATER

Product Characteristics Color YELLOW, PURPLE Score no score Shape CAPSULE Size 22mm Flavor BLACKBERRY Imprint Code Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:52183-212-25 25 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 07/01/2017

Labeler — Prestige Brands Holdings, Inc. (159655021)

Revised: 05/2017 Prestige Brands Holdings, Inc.