FDA Label for Pedia-lax
View Indications, Usage & Precautions
Pedia-lax Product Label
The following document was submitted to the FDA by the labeler of this product C.b. Fleet Company, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredients
(in each 15 mL)
Docusate Sodium 50 mg
Purpose
Stool softener
Uses
- for prevention of dry, hard stools
- for relief of occasional constipation
- this product usually produces a bowel movement in 12 to 72 hours
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.
Keep Out Of Reach Of Children
In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
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).
Other Information
- each 15 mL contains: sodium 13 mg
- the top of the bottle is sealed with foil for your safety. Do not use if foil imprinted "sealed for your protection" is broken or missing.
- gluten free
Inactive Ingredients
citric acid, edetate disodium, flavor, methylparaben, polyethylene glycol, povidone, propylene glycol, propylparaben, sodium citrate, sorbitol, sucralose, water, xanthan gum, xylitol
Questions?
1-866-255-6960 or www.pedia-lax.com
Principal Display Panel
Pedia-Lax
Docusate sodium
Liquid Stool Softener
4 fl oz (118 mL)
* Please review the disclaimer below.