Pectin

Pectin
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Kiran Singh, M.D. [2]

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NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Overview

Pectin is a demulcent that is FDA approved for the treatment of symptoms associated with sore mouth and sore throat. Common adverse reactions include diarrhea, gas, and loose stools.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

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

• Minor discomfort
• Irritated areas

Dosage

• Adults: dissolve 1 or 2 drops (one at a time) slowly in the mouth. Repeat as needed.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Pectin in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Pectin in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Indications

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

• Minor discomfort
• Irritated areas

Dosage

• Children 5 years and over: dissolve 1 or 2 drops (one at a time) slowly in the mouth. Repeat as needed.

• Children under 5 years, ask a doctor.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Pectin in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Pectin in pediatric patients.

Contraindications

There is limited information regarding Contraindications of Pectin in patientspatients.

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.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Adverse Reactions of Pectin in patients.

Postmarketing Experience

There is limited information regarding postmarketing experience of Pectin in patients.

Drug Interactions

There is limited information regarding <Drug Interactions/i> of Pectin in patients.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is limited information regarding FDA Pregnancy Category/i> of Pectin in patients.
Pregnancy Category (AUS): There is limited information regarding Australian pregnancy category/i> of Pectin in patients.

Labor and Delivery

There is no FDA guidance on use of Pectin during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Pectin in women who are nursing.

Pediatric Use

There is no FDA guidance on the use of Pectin in pediatric settings.

Geriatic Use

There is no FDA guidance on the use of Pectin in geriatric settings.

Gender

There is no FDA guidance on the use of Pectin with respect to specific gender populations.

Race

There is no FDA guidance on the use of Pectin with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Pectin in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Pectin in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Pectin in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Pectin in patients who are immunocompromised.

Others

Administration and Monitoring

Administration

• Oral

Monitoring

There is limited information regarding Pectin Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Pectin and IV administrations.

Overdosage

There is limited information regarding drug overdose/i> of Pectin in patients

Pharmacology

There is limited information regarding Pectin Pharmacology in the drug label.

Mechanism of Action

There is limited information regarding Pectin Mechanism of Action in the drug label.

Structure

There is limited information regarding Pectin Structure in the drug label.

Pharmacodynamics

There is limited information regarding Pectin Pharmacodynamics in the drug label.

Pharmacokinetics

There is limited information regarding Pectin Pharmacokinetics in the drug label.

Nonclinical Toxicology

There is limited information regarding Pectin Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding Pectin Clinical Studies in the drug label.

How Supplied

There is limited information regarding Pectin How Supplied in the drug label.

Storage

There is limited information regarding Pectin Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

STOP USE AND ASK A DOCTOR IF

• Sore mouth does not improve in 7 days
• Irritation, pain, or redness persists or worsens

Precautions with Alcohol

Alcohol-Pectin interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

BREEZERS COOL BERRY

Look-Alike Drug Names

There is limited information regarding Pectin Look-Alike Drug Names in the drug label.

Drug Shortage Status

Drug Shortage

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

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