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

Purpose

Oral demulcent

Description

Drug Facts


Medication Information

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.

Uses

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

Purpose

Oral demulcent

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°-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

Description

Drug Facts

Principal Display Panel

Luden’s

Pectin Lozenge/ Oral Demulcent

Assorted flavors

Wild Cherry • Watermelon • Honey & Berry

90 Throat Drops

Questions?

  1-866-583-3677   Ludens.com

A

Pectin 2.8 mg

Section 42229-5

Drug Facts

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

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.

Uses

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

Purpose

Oral demulcent

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 (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

Questions?

  1-866-583-3677   Ludens.com

A

Pectin 2.8 mg

Section 42229-5 (42229-5)

Drug Facts

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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