Active Ingredient
Magnesium hydroxide 400 mg
Childrens Oral Saline Laxative Tablet, Chewable
FDA Label NDC 49035-307
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Wal-mart Stores,inc., for the product Childrens Oral Saline Laxative (NDC 49035-307). 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, 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
- 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?
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*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.
