Polyethylene glycol

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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
Polyethylene glycol is a Laxative that is FDA approved for the treatment of constipation.   Common adverse reactions include Diarrhea, Flatulence, Nausea, Stomach cramps.

# Adult Indications and Dosage

## FDA-Labeled Indications and Dosage (Adult)

### Indications
- relieves occasional constipation (irregularity)
- generally produces a bowel movement in 1 to 3 days

### Directions
- do not take more than directed unless advised by your doctor
- the enclosed scoop is a measuring device designed to contain 17 grams of powder when filled to the top (level scoop)
- adults and children 17 years of age and older:
- fill scoop completely with product to obtain the correct dose (17 g). Level scoop with knife or flat object.
- stir and dissolve in any 4 to 8 ounces of beverage (cold, hot or room temperature) then drink
- use once a day
- use no more than 7 days
- children 16 years of age or under: ask a doctor

## Off-Label Use and Dosage (Adult)

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

### NonGuideline-Supported Use
There is limited information regarding Off-Label NonGuideline-Supported Use of Polyethylene glycol in adult patients.

# Pediatric Indications and Dosage

## FDA-Labeled Indications and Dosage (Pediatric)
safety and effectiveness not established in children

## Off-Label Use and Dosage (Pediatric)

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

### NonGuideline-Supported Use
There is limited information regarding Off-Label NonGuideline-Supported Use of Polyethylene glycol in pediatric patients.

# Contraindications
There is limited information regarding Polyethylene glycol Contraindications in the drug label.

# Warnings
- Allergy alert: Do not use if you are allergic to polyethylene glycol
- Do not use
- if you have kidney disease, except under the advice and supervision of a doctor
- Ask a doctor before use if you have
- nausea, vomiting or abdominal pain
- a sudden change in bowel habits that lasts over 2 weeks
- irritable bowel syndrome
- Ask a doctor or pharmacist before use if you are
- taking a prescription drug
- When using this product
- you may have loose, watery, more frequent stools
- Stop use and ask a doctor if
- you have rectal bleeding or your nausea, bloating, cramping or abdominal pain gets worse. These may be signs of a serious condition.
- you get diarrhea
- you need to use a laxative for longer than 1 week
- If pregnant or breast-feeding,
- ask a health professional before use.
- Keep out of reach of children.
- In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

# Adverse Reactions

## Clinical Trials Experience
There is limited information regarding Clinical Trial Experience of Polyethylene glycol in the drug label.

## Postmarketing Experience
- Diarrhea, Flatulence, Nausea, Stomach cramps

# Drug Interactions
There is limited information regarding Polyethylene glycol Drug Interactions in the drug label.

# Use in Specific Populations

### Pregnancy
Pregnancy Category (FDA):
- If pregnant or breast-feeding,
ask a health professional before use.
Pregnancy Category (AUS):
- Australian Drug Evaluation Committee (ADEC) Pregnancy Category
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Polyethylene glycol in women who are pregnant.

### Labor and Delivery
There is no FDA guidance on use of Polyethylene glycol during labor and delivery.

### Nursing Mothers
If pregnant or breast-feeding,
ask a health professional before use.

### Pediatric Use
safety and effectiveness not established in children

### Geriatic Use
There is no FDA guidance on the use of Polyethylene glycol with respect to geriatric patients.

### Gender
There is no FDA guidance on the use of Polyethylene glycol with respect to specific gender populations.

### Race
There is no FDA guidance on the use of Polyethylene glycol with respect to specific racial populations.

### Renal Impairment
There is no FDA guidance on the use of Polyethylene glycol in patients with renal impairment.

### Hepatic Impairment
There is no FDA guidance on the use of Polyethylene glycol in patients with hepatic impairment.

### Females of Reproductive Potential and Males
There is no FDA guidance on the use of Polyethylene glycol in women of reproductive potentials and males.

### Immunocompromised Patients
There is no FDA guidance one the use of Polyethylene glycol in patients who are immunocompromised.

# Administration and Monitoring

### Administration
- Oral

### Monitoring
There is limited information regarding Monitoring of Polyethylene glycol in the drug label.

# IV Compatibility
There is limited information regarding IV Compatibility of Polyethylene glycol in the drug label.

# Overdosage
In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

# Pharmacology

## Mechanism of Action

## Structure
- ACTIVE INGREDIENT (IN EACH DOSE)
Polyethylene Glycol 3350, 17 g (in each level scoop)

## Pharmacodynamics
There is limited information regarding Pharmacodynamics of Polyethylene glycol in the drug label.

## Pharmacokinetics
There is limited information regarding Pharmacokinetics of Polyethylene glycol in the drug label.

## Nonclinical Toxicology
There is limited information regarding Nonclinical Toxicology of Polyethylene glycol in the drug label.

# Clinical Studies
There is limited information regarding Clinical Studies of Polyethylene glycol in the drug label.

# How Supplied

## Storage
- store at 20-25C (68-77F)
- tamper-evident: do not use if printed foil seal under cap is missing, open or broken

# Images

## Drug Images

## Package and Label Display Panel

### PRINCIPAL DISPLAY PANEL

### Ingredients and Appearance

# Patient Counseling Information
QUESTIONS OR COMMENTS?

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

# Brand Names
- CLEAR LAX

# Look-Alike Drug Names
There is no information regarding look alike drug names

# Drug Shortage Status

# Price