Drugplain

Pedia-Lax 3.5 g/66mL

sodium phosphate, dibasic and sodium phosphate, monobasic · ENEMA · C.B. Fleet Company, Inc.

1 Recall on RecordCurrently in Shortage
Plain English

Pedia-Lax is an over-the-counter rectal enema used to relieve constipation in children and help empty the bowel. It works by drawing water into the intestines to soften stool and promote bowel movements.

Key Facts

Brand Name
Pedia-Lax
Generic Name
sodium phosphate, dibasic and sodium phosphate, monobasic
NDC Code (Product)
0132-0202
Manufacturer
C.B. Fleet Company, Inc.
Strength
3.5 g/66mL
Dosage Form
ENEMA
Route
RECTAL
Marketing Status
Application #
M007
Marketing Start
05/10/2002

Recall History

1 Recall on Record
Class II03/15/2021

Cardinal Health Inc.

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

constipation2,146 reports
nausea2,100 reports
pain1,996 reports
fatigue1,753 reports
off label use1,642 reports
fall1,637 reports
dyspnoea1,615 reports
drug ineffective1,591 reports
diarrhoea1,470 reports
vomiting1,429 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses for prevention of dry, hard stools for relief of occasional constipation this product usually produces a bowel movement in 12 to 72 hours

Dosage & Administration

Directions do not give more than 45 mL in any 24 hour period use only with enclosed dosing cup find right dose on chart below mL = milliliter Age Dose Children 2 to under 12 years 15 mL to 45 mL; do not take more than 45 mL in 24 hours Children under 2 years ask a doctor Doses can be diluted in a suitable beverage to prevent throat irritation and to help mask the naturally tart flavor of the active ingredient (see side panel for info).

Warnings

Warnings Drug Interaction Precaution: Do not give this product to your child if your child is presently taking mineral oil, unless directed by a doctor. Ask a doctor before using any laxative if your child has a sudden change in bowel habits lasting more than 2 weeks already used a laxative for more than 1 week If constipation continues after 1 week of use, contact your child's doctor Stop using this product and consult a doctor if your child has rectal bleeding no bowel movement within 72 hours of using this product These symptoms may be signs of a serious condition.

Frequently Asked Questions

What is Pedia-Lax used for?

Pedia-Lax is an over-the-counter rectal enema used to relieve constipation in children and help empty the bowel. It works by drawing water into the intestines to soften stool and promote bowel movements.

Is Pedia-Lax a controlled substance?

Pedia-Lax is not classified as a controlled substance by the DEA.

What is the generic name for Pedia-Lax?

The generic name for Pedia-Lax is sodium phosphate, dibasic and sodium phosphate, monobasic. There are 7 other brand versions of sodium phosphate, dibasic and sodium phosphate, monobasic.

What is the NDC code for Pedia-Lax 3.5 g/66mL?

The NDC (National Drug Code) for Pedia-Lax 3.5 g/66mL is 0132-0202, listed by C.B. Fleet Company, Inc..

Product NDC

0132-0202

Package NDC

0132-0202-20

Other Sodium Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)