Active Ingredient (In Each 59-Ml Delivered Dose)
Monobasic Sodium Phosphate 9.5 g, Saline Laxative
Dibasic Sodium Phosphate 3.5 g, Saline Laxative
Pedia-lax Enema
FDA Label NDC 0132-0202
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by C.b. Fleet Company, Inc. for the product Pedia-lax (NDC 0132-0202). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient (in each 59-ml delivered dose), use, warnings, ask a doctor before using this product if the child, stop use and ask a doctor if the child has, keep out of reach of children to prevent accidental ingestion., directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Use
For relief of occasional constipation.
Warnings
For rectal use only
Dosage Warning:
Using more than one enema in 24 hours can be harmful. Do not use without asking a doctor:
- for more than 3 days
- if your child has kidney disease
- if your child has heart problems
- if your child is dehydrated
Ask A Doctor Before Using This Product If The Child
- is on a sodium-restricted diet
- abdominal pain, nausea, or vomiting
- a sudden change in bowel habits lasting more than 2 weeks
- already used a laxative for more than 1 week
Ask a doctor before using any laxative if your child has
Stop Use And Ask A Doctor If The Child Has
- rectal bleeding
- no bowel movement or no liquid comes out of the child's rectum after 30 minutes
- symptoms of dehydration (feeling thirsty, dizziness, vomiting or urinating less often than normal)
These symptoms may indicate a serious condition.
Keep Out Of Reach Of Children To Prevent Accidental Ingestion.
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
Single Daily Dosage (per 24 hours)
Do not use more unless directed by a doctor. See Warnings.
Do not use if child is taking another sodium phosphates product.
| children 5 to 11 years | 1 bottle per day or as directed by a doctor |
| children 2 to under 5 years | one-half bottle per day (see below) |
| children under 2 years | DO NOT USE |
One-half bottle prepararation: Unscrew cap and remove 2 tablespoons of liquid with a measuring spoon. Replace cap and follow "How to use this enema" directions.
Other Information
- each 59-mL delivered dose contains: sodium 2.2 g
- additional liquids by mouth are recommended while taking this product
- this product generally produces a bowel movement in 1-5 minutes
- BOTTLE SEALED FOR SAFETY. IF BOTTLE WRAPPER WITH FLEET EMBLEM IS TORN, DAMAGED OR MISSING, DO NOT USE
- for complete professional use warnings and precautions, consult the Reference Safety Information on our website
Inactive Ingredients
benzalkonium chloride, disodium EDTA, purified water
Questions?
1-866-255-6960
www.pedia-lax.com
* Please review the disclaimer below.
