Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID c53c19a9-5984-4b08-ae46-a53dc8bb7d74
Route
ORAL
Published
Effective Date 2025-05-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Pectin (7 mg)
Inactive Ingredients
Sucrose Corn Syrup Citric Acid Soybean Lecithin Fd&c Blue No. 1 Fd&c Red No. 40 Sodium Citrate, Unspecified Form

Identifiers & Packaging

Pill Appearance
Imprint: F Shape: oval Color: red Size: 20 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-06-14

Description

Pectin 7mg 

Purpose

Oral demulcent


Medication Information

Purpose

Oral demulcent

Description

Pectin 7mg 

Use

Temporarily relieves the following symptoms associated with sore mouth and sore throat:

  • minor discomfort
  • irritated areas
Section 50565-1

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 doctor if: Sore mouth does not improve in 7 days Irritation, pain or redness persists or worsens

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions
  • Adults and children 5 years and over: dissolve 1 or 2 drops (one at a time) slowly in mouth. Repeat as needed.
  • Children under 5 years: ask a doctor

Product Label

Active Ingredient

Pectin 7mg 

Other Information
  • 11 calories per drop 
  • Contains : Soy
Inactive Ingredients

Citric acid, FD&C blue 1, FD&C red 40, glucose syrup, natural & artificial flavors, sodium citrate, soy lecithin, sucrose, water.


Structured Label Content

Use

Temporarily relieves the following symptoms associated with sore mouth and sore throat:

  • minor discomfort
  • irritated areas
Section 50565-1 (50565-1)

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.

Stop use and ask doctor if: Sore mouth does not improve in 7 days Irritation, pain or redness persists or worsens

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions
  • Adults and children 5 years and over: dissolve 1 or 2 drops (one at a time) slowly in mouth. Repeat as needed.
  • Children under 5 years: ask a doctor

Product Label (Product label)

Active Ingredient

Pectin 7mg 

Other Information (Other information)
  • 11 calories per drop 
  • Contains : Soy
Inactive Ingredients (Inactive ingredients)

Citric acid, FD&C blue 1, FD&C red 40, glucose syrup, natural & artificial flavors, sodium citrate, soy lecithin, sucrose, water.


Advanced Ingredient Data


Raw Label Data

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