Ludens Assorted Flavors

Ludens Assorted Flavors
SPL v3
SPL
SPL Set ID 60d6da81-e128-4a9b-88de-39c48511196f
Route
ORAL
Published
Effective Date 2024-10-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Pectin (2.8 mg)
Inactive Ingredients
Ascorbic Acid Citric Acid Monohydrate Corn Syrup Fd&c Blue No. 2 Fd&c Red No. 40 Malic Acid Sodium Acetate Sodium Chloride Soybean Oil Sucrose Water Caramel Fd&c Blue No. 1 Honey

Identifiers & Packaging

Pill Appearance
Imprint: LUDENS Shape: oval Color: red Color: yellow Size: 23 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2017-06-13

Description

Drug Facts

Purpose

Oral demulcent


Medication Information

Purpose

Oral demulcent

Description

Drug Facts

A

Pectin 2.8 mg

Uses

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

Section 42229-5

Drug Facts

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

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

Questions?

  1-866-583-3677   Ludens.com

Other Information

store at 20°-25°C (68°-77°F) in a dry place

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

Principal Display Panel

Luden’s

Pectin Lozenge/ Oral Demulcent

Assorted flavors

Wild Cherry • Watermelon • Honey & Berry

90 Throat Drops

Stop Use and Ask A Doctor If

• sore mouth does not improve in 7 days

• irritation, pain or redness persists or worsens


Structured Label Content

A

Pectin 2.8 mg

Uses

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

Section 42229-5 (42229-5)

Drug Facts

Purpose

Oral demulcent

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

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

Questions?

  1-866-583-3677   Ludens.com

Other Information (Other information)

store at 20°-25°C (68°-77°F) in a dry place

Inactive Ingredients (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

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Luden’s

Pectin Lozenge/ Oral Demulcent

Assorted flavors

Wild Cherry • Watermelon • Honey & Berry

90 Throat Drops

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

• sore mouth does not improve in 7 days

• irritation, pain or redness persists or worsens


Advanced Ingredient Data


Raw Label Data

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