Active Ingredient
Magnesium hydroxide 400 mg
Pedia-lax Tablet, Chewable
FDA Label NDC 0132-0655
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 0132-0655). 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, purpose, uses, ask a doctor before using any laxative if child has, stop use and consult a doctor if your 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
Purpose
Saline laxative
Uses
- for relief of occasional constipation
- this product usually produces bowel movement in 1/2 to 6 hours
Ask A Doctor Before Using Any Laxative If Child Has
- kidney disease
- a magnesium-restricted diet
- abdominal pain, nausea or vomiting
- a sudden change in bowel habits lasting more than 2 weeks
- constipation continues after 1 week of use, contact your child's doctor
- already used a laxative for more than 1 week
Stop Use And Consult A Doctor If Your Child Has
- rectal bleeding
- no bowel movement within 6 hours of using this product
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
Use dosage chart for proper dosing. Doses may be taken as a single daily dose or in divided doses. Drink a full glass (8 ounces) of liquid with each dose.
| Age | Starting dose | Starting Dose Maxiumm dose per day (24 hours) |
| children 6 to under 12 years | 3-6 tablets | 6 tablets |
| children 2 to under 6 years | 1-3 tablets | 3 tablets |
| children under 2 years | ask a doctor |
Other Information
- each tablet contains: 170 mg of magnesium
- CHILD RESISTANT CAP
- The top of the bottle sealed for safety.Do not use if foil impreinted "SEALED for YOUR PROTECTION" is broken of missing.
- Gluten Free and Sugar Free
Inactive Ingredients
colloidal silicon dioxide, FD&C red #40 aluminum lake, flavor, magnesium stearate, maltodextrin, mannitol, sorbitol, stearic acid, sucralose
Questions?
1-866-255-6960 or www.pedia-lax.com
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Pedia-Lax Chewable Tablets
Saline Laxative
30 chewable tablets
* Please review the disclaimer below.
