Ludens Honey Lemon

Ludens Honey Lemon
SPL v3
SPL
SPL Set ID 92e69995-3eeb-4810-9639-c0246bacc7ac
Route
ORAL
Published
Effective Date 2025-01-17
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 Yellow No. 5 Honey Lemon Oil Sodium Acetate Sodium Chloride Sucrose Water

Identifiers & Packaging

Pill Appearance
Shape: oval Color: yellow Size: 23 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Completed Since 2018-02-01 Until 2024-10-01

Description

Drug Facts

Purpose

Oral demulcent


Medication Information

Purpose

Oral demulcent

Description

Drug Facts

P

Luden’s ®  

Honey Lemon

Pectin lozenge/ oral demulcent

25 Throat Drops

Luden’s ®  

Honey Lemon

Pectin lozenge/ oral demulcent      

90 Throat Drops

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

Active Ingredient

Pectin 2.8 mg

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

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

P

Luden’s ®  

Honey Lemon

Pectin lozenge/ oral demulcent

25 Throat Drops

Luden’s ®  

Honey Lemon

Pectin lozenge/ oral demulcent      

90 Throat Drops

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

Active Ingredient (Active ingredient)

Pectin 2.8 mg

Other Information (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 (Inactive ingredients)

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

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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