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 tablespoon)
Docusate sodium 50 mg, Stool softener
Uses
- for the prevention of dry, hard stools
- for relief of occasional constipation
- this product generally produces bowel movement in 12-72 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
- 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
- if constipation continues after 1 week of use, contac your child's doctor
Stop Using This Product And Consult A Doctor If Your Child Has
- rectal bleeding
- no bowel movement within 72 horus 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 right away.
Directions
Use dosage chart for proper dosing. Doses may be taken as a single daily dose or in divided doses. Doses can be given in a glass of juice to prevent throat irritation and to help mask the naturally tart flavor of the active ingredient.
| Age | Starting Dose | Maximum dose per day (24 hours) |
| children 2 to 12 years | 1 - 3 tablespoons | 3 tablespoons |
| children under 2 years | ask a doctor |
Other Information
- each tablespoon contains: sodium 13 mg
- CHILD RESISTANT CAP
- 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, FD and C red 3, 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
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