Methylcellulose

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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
Methylcellulose is a OTC laxative that is FDA approved for the treatment of constipation.   Common adverse reactions include flatulence and distension.

# Adult Indications and Dosage

## FDA-Labeled Indications and Dosage (Adult)

### Indications
- helps restore and maintain regularity
- relieves constipation (irregularity)
- for constipation associated with other bowel disorders like IBS when recommended by a doctor
- generally produces a bowel movement in 12- 72 hours

### Dosage
- Take this product (child or adult dose) with at least 8 ounces (a full glass) of water or other fluid. Taking this product without enough liquid may case choking. See choking warning.

## Off-Label Use and Dosage (Adult)

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

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

# Pediatric Indications and Dosage

## FDA-Labeled Indications and Dosage (Pediatric)

### Dosage
- Take this product (child or adult dose) with at least 8 ounces (a full glass) of water or other fluid. Taking this product without enough liquid may case choking. See choking warning.

## Off-Label Use and Dosage (Pediatric)

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

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

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

# Warnings
- Choking: taking this product without adequate fluid may cause it to swell and block your throat or esophagus and may cause choking. Do not take this product if you have difficulty in swallowing. If you experience chest pain, vomiting, or difficulty in swallowing or breathing after taking this product, seek immediate medical attention.
- Ask a doctor before use if you have
- a sudden change in bowel habits that persists for two weeks
- abdominal pain, nausea or vomiting
- Stop use and ask a doctor if
- constipation lasts more than 7 days
- you have rectal bleeding
- These could be signs of a serious condition.
- Keep out of reach of children.
- In case of overdose, get medical help or contact a Poison Control Center right away.

# Adverse Reactions

## Clinical Trials Experience
- flatulence
- distension
- intestinal obstruction

## Postmarketing Experience
There is limited information regarding Postmarketing Experience of Methylcellulose in the drug label.

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

# Use in Specific Populations

### Pregnancy
Pregnancy Category (FDA): 
There is no FDA guidance on usage of Methylcellulose in women who are pregnant.
Pregnancy Category (AUS):
- Australian Drug Evaluation Committee (ADEC) Pregnancy Category
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Methylcellulose in women who are pregnant.

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

### Nursing Mothers
There is no FDA guidance on the use of Methylcellulose with respect to nursing mothers.

### Pediatric Use
There is no FDA guidance on the use of Methylcellulose with respect to pediatric patients.

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

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

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

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

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

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

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

# Administration and Monitoring

### Administration
- Oral

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

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

# Overdosage
There is limited information regarding Overdose of Methylcellulose in the drug label.

# Pharmacology

## Mechanism of Action
- Bulk-forming fiber laxative

## Structure
- Methylcellulose (a non-allergenic fiber) 500mg
- crospovidone, dibasic calcium phosphate, FD&C yellow no. 6 aluminum lake, magnesium stearate, maltodextrin, povidone, sodium lauryl sulfate
- each caplet contains: calcium 10mg

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

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

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

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

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

## Storage
- store below 77 oF (25 oC)
- protect contents from humidity
- keep tightly closed

# Images

## Drug Images

## Package and Label Display Panel

### PRINCIPAL DISPLAY PANEL
NDC 0135-0199-02
CITRUCEL
METHYLCELLULOSE FIBER THERAPY FOR REGULARITY
Gentle and clinically proven effective
Gives you additional fiber to help balance your diet
The ONLY fiber for regularity that wont cause excess gas
100 Fiber caplets
BETTER VALUE Per Dose than leading competition
- Based on laboratory testing. Individual results may vary.
CITRUCEL is a registered trademark of the Sanofi group of companies and licensed by the GlaxoSmithKline group of companies.
2012 GlaxoSmithKline
101878XA

### Ingredients and Appearance

# Patient Counseling Information
- call toll-free 1-800-897-6081 (English/Spanish) weekdays

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

# Brand Names
- CITRUCEL

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

# Drug Shortage Status

# Price