Pectin

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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.

### NonGuideline-Supported Use
There is limited information regarding Off-Label NonGuideline-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.

### NonGuideline-Supported Use
There is limited information regarding Off-Label NonGuideline-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  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

## Package and Label Display Panel

# 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