FDA Label for Childrens Oral Saline Laxative
View Indications, Usage & Precautions
Childrens Oral Saline Laxative Product Label
The following document was submitted to the FDA by the labeler of this product Wal-mart Stores,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 Ingredient
Magnesium hydroxide 400 mg
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
• has rectal bleeding• does not have a bowel movement within 6 hours of taking this product
These symptoms may indicate a serious condition.
Keep Out Of Reach Of Children
In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222.
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 | Maximum dose per day |
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: magnesium 170 mg• store at room temperature
Inactive Ingredients
dextrose, FD&C Red 40 aluminum lake, magnesium stearate, maltodextrin, natural & artificial flavor, sorbitol, starch, sucralose.
Questions Or Comments?
1-866-467-2748
Principal Display Panel
*Compare to the active ingredient in Pedia-Lax®
NDC# 49035-307-30
Children’s Oral Saline Laxative
• Treats constipation• Relief in ½ to 6 hours• Safe and gentle for kids
For ages 2-11 years
Watermelon Flavor
Naturally and Artificially Flavored
30 Chewable Tablets
IMPORTANT: Keep this carton for future reference on full labeling. |
Poop Should Just Happen.
These tablets are designed for quick, yet gentle relief in 30 minutes to 6 hours. Tasty watermelon-flavored chewable tablets are appropriately dosed for children and allow relief without the painful cramping sometimes associated with stimulant laxatives.
Distributed by:
Wal-Mart Stores, Inc., Bentonville, AR 72716
*This product is not manufactured or distributed by C.B. Fleet Company Inc., the distributor of Pedia-Lax®.
* Please review the disclaimer below.