Children’s Oral Saline Laxative Chewable Tablets

Drug Facts

Composition & Product

Active Ingredients

Hydroxide Ion (400 mg)

Inactive Ingredients

Dextrose, Unspecified Form Fd&c Red No. 40 Watermelon Magnesium Stearate Maltodextrin Sorbitol Starch, Corn Sucralose

Identifiers & Packaging

Pill Appearance

Imprint: RP129 Shape: round Color: pink Size: 14 mm Score: 2

Marketing Status

OTC MONOGRAPH DRUG Active Since 2020-03-10

Medication Information

Purpose

Saline laxative

Description

Magnesium hydroxide 400 mg

uses

for relief of occasional constipation
this product usually produces bowel movement in 1/2 to 6 hours

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.

active Ingredient

Magnesium hydroxide 400 mg

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 ^®.

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.

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.

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

Structured Label Content

Purpose

Saline laxative

uses (Uses)

for relief of occasional constipation
this product usually produces bowel movement in 1/2 to 6 hours

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 (Other information)

each tablet contains: magnesium 170 mg
store at room temperature

Inactive Ingredients (Inactive ingredients)

dextrose, FD&C Red 40 aluminum lake, magnesium stearate, maltodextrin, natural & artificial flavor, sorbitol, starch, sucralose.

active Ingredient (Active Ingredient)

Magnesium hydroxide 400 mg

Questions Or Comments? (Questions or comments?)

1-866-467-2748

Principal Display Panel (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 ^®.

Keep Out of Reach of Children (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.

Stop Use and Consult A Doctor If Your Child Has (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.

Ask A Doctor Before Using Any Laxative If Child Has (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

Advanced Ingredient Data

[{"name": "DEXTROSE, UNSPECIFIED FORM", "unii": "IY9XDZ35W2", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C RED NO. 40", "unii": "WZB9127XOA", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATERMELON", "unii": "231473QB6R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MALTODEXTRIN", "unii": "7CVR7L4A2D", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITOL", "unii": "506T60A25R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STARCH, CORN", "unii": "O8232NY3SJ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SUCRALOSE", "unii": "96K6UQ3ZD4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYDROXIDE ION", "unii": "9159UV381P", "classCode": "ACTIB", "strengthNumerator": "400", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}]

Raw Label Data

All Sections (JSON)

{"Purpose": "Saline laxative", "Uses": "for relief of occasional constipation this product usually produces bowel movement in 1/2 to 6 hours", "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.", "Active Ingredient": "Magnesium hydroxide 400 mg", "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 ® .", "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.", "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.", "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"}

Children’s Oral Saline Laxative Chewable Tablets

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information