pedia-lax enema saline laxative 0132-0202

SPL v11

SPL

SPL Set ID f001a37d-8ed4-428b-af12-d6a83c22c127

Route

rectal

Published

Effective Date 2024-12-12

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

sodium cation (3.5 g) phosphate ion (9.5 g)

Inactive Ingredients

edetate disodium water benzalkonium chloride

Identifiers & Packaging

Marketing Status

otc monograph drug active Since 2002-05-10

Purpose

Saline laxative Saline laxative

Description

PEDIA-LAX sodium phosphates Saline Enema C.B. Fleet Company, Inc. ---------- Drug Facts

Medication Information

Warnings

For rectal use only.

Dosage Warning:

Using more than one enema in 24 hours can be harmful.

Purpose

Saline laxative

Directions

Single Daily Dosage (per 24 hours)

Do not use more per day unless directed by a doctor. See Warnings .

Do not use if child is taking another sodium phosphates product.

Age	Dose
children 5 to 11 years	1 bottle per day or as directed by doctor
children 2 to under 5 years	one-half bottle per day (see below)
children under 2 years	DO NOT USE

One-half bottle preparation:

Unscrew cap and remove 2 tablesppons of liquid with a measuring spoon. Replace cap and follow “How to use this enema” directions.

Other Information

each 59-mL delivered dose contains: sodium 2.2g
additional liquids by mouth are recommended while taking this product
this product usually produces a bowel movement in 1-5 minutes
BOTTLE SEALED FOR SAFETY. IF BOTTLE WRAPPER WITH FLEET ^® EMBLEM IS TORN, DAMAGED, OR MISSING, DO NOT USE
for complete professional use, warnings and precautions, consult the Reference Safety Information on our website

Inactive Ingredients

benzalkonium chloride, disodium EDTA, purified water

Description

PEDIA-LAX sodium phosphates Saline Enema C.B. Fleet Company, Inc. ---------- Drug Facts

Principal Display Panel

Pedia-Lax

Sodium Phosphates

Saline Enema

2.25 fl oz (66 mL)

Questions?

1-866-255-6960

www.pedia-lax.com

Fleet ^® Enemas are LATEX-FREE

Use

for relief of occasional constipation.

Stop

rectal bleeding
no bowel movement or no liquid comes out of the child’s rectum after 30 minutes
symptoms of dehydration [feeling thirsty, dizziness, vomiting, urinating less often than normal]

These symptoms may indicate a serious condition.

Section 42229-5

PEDIA-LAX sodium phosphates Saline Enema

C.B. Fleet Company, Inc.

----------

Drug Facts

Do Not Use

for more than 3 days
if your child has a kidney disease
if your child has heart problems
if your child is dehydrated

Active Ingredients

(in each 59-mL delivered dose)

Monobasic Sodium Phosphate 9.5 g................

Dibasic Sodium Phosphate 3.5 g........................

Keep Out of Reach of Children

If swallowed, get medical help or contact a Poison Control Center right away.

Ask A Doctor Before Using This Product If the Child

is on a sodium-restricted diet

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

Structured Label Content

Warnings

For rectal use only.

Dosage Warning:

Using more than one enema in 24 hours can be harmful.

Purpose

Saline laxative

Directions

Single Daily Dosage (per 24 hours)

Do not use more per day unless directed by a doctor. See Warnings .

Do not use if child is taking another sodium phosphates product.

Age	Dose
children 5 to 11 years	1 bottle per day or as directed by doctor
children 2 to under 5 years	one-half bottle per day (see below)
children under 2 years	DO NOT USE

One-half bottle preparation:

Unscrew cap and remove 2 tablesppons of liquid with a measuring spoon. Replace cap and follow “How to use this enema” directions.

Other Information (Other information)

each 59-mL delivered dose contains: sodium 2.2g
additional liquids by mouth are recommended while taking this product
this product usually produces a bowel movement in 1-5 minutes
BOTTLE SEALED FOR SAFETY. IF BOTTLE WRAPPER WITH FLEET ^® EMBLEM IS TORN, DAMAGED, OR MISSING, DO NOT USE
for complete professional use, warnings and precautions, consult the Reference Safety Information on our website

Inactive Ingredients

benzalkonium chloride, disodium EDTA, purified water

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Pedia-Lax

Sodium Phosphates

Saline Enema

2.25 fl oz (66 mL)

Questions?

1-866-255-6960

www.pedia-lax.com

Fleet ^® Enemas are LATEX-FREE

Use

for relief of occasional constipation.

Stop

rectal bleeding
no bowel movement or no liquid comes out of the child’s rectum after 30 minutes
symptoms of dehydration [feeling thirsty, dizziness, vomiting, urinating less often than normal]

These symptoms may indicate a serious condition.

Section 42229-5 (42229-5)

PEDIA-LAX sodium phosphates Saline Enema

C.B. Fleet Company, Inc.

----------

Drug Facts

Do Not Use (Do not use)

for more than 3 days
if your child has a kidney disease
if your child has heart problems
if your child is dehydrated

Active Ingredients

(in each 59-mL delivered dose)

Monobasic Sodium Phosphate 9.5 g................

Dibasic Sodium Phosphate 3.5 g........................

Keep Out of Reach of Children (Keep out of reach of children)

If swallowed, get medical help or contact a Poison Control Center right away.

Ask A Doctor Before Using This Product If the Child (Ask a doctor before using this product if the child)

is on a sodium-restricted diet

Ask A Doctor Before Using Any Laxative If Your Child Has (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

Advanced Ingredient Data

[{"name": "SODIUM CATION", "unii": "LYR4M0NH37", "classCode": "ACTIB", "strengthNumerator": "3.5", "strengthDenominator": "66", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "PHOSPHATE ION", "unii": "NK08V8K8HR", "classCode": "ACTIB", "strengthNumerator": "9.5", "strengthDenominator": "66", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "EDETATE DISODIUM", "unii": "7FLD91C86K", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BENZALKONIUM CHLORIDE", "unii": "F5UM2KM3W7", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Use": "for relief of occasional constipation.", "Stop": "rectal bleeding no bowel movement or no liquid comes out of the child’s rectum after 30 minutes symptoms of dehydration [feeling thirsty, dizziness, vomiting, urinating less often than normal] These symptoms may indicate a serious condition.", "42229-5": "PEDIA-LAX sodium phosphates Saline Enema C.B. Fleet Company, Inc. ---------- Drug Facts", "Purpose": "Saline laxative Saline laxative", "Warnings": "For rectal use only. Dosage Warning: Using more than one enema in 24 hours can be harmful.", "Directions": "Single Daily Dosage (per 24 hours) Do not use more per day unless directed by a doctor. See Warnings . Do not use if child is taking another sodium phosphates product. Age Dose children 5 to 11 years 1 bottle per day or as directed by doctor children 2 to under 5 years one-half bottle per day (see below) children under 2 years DO NOT USE One-half bottle preparation: Unscrew cap and remove 2 tablesppons of liquid with a measuring spoon. Replace cap and follow “How to use this enema” directions.", "Do not use": "for more than 3 days if your child has a kidney disease if your child has heart problems if your child is dehydrated", "Questions?": "1-866-255-6960 www.pedia-lax.com Fleet ® Enemas are LATEX-FREE", "Other information": "each 59-mL delivered dose contains : sodium 2.2g additional liquids by mouth are recommended while taking this product this product usually produces a bowel movement in 1-5 minutes BOTTLE SEALED FOR SAFETY. IF BOTTLE WRAPPER WITH FLEET ® EMBLEM IS TORN, DAMAGED, OR MISSING, DO NOT USE for complete professional use, warnings and precautions, consult the Reference Safety Information on our website", "Active Ingredients": "(in each 59-mL delivered dose) Monobasic Sodium Phosphate 9.5 g................ Dibasic Sodium Phosphate 3.5 g........................", "Inactive Ingredients": "benzalkonium chloride, disodium EDTA, purified water", "PRINCIPAL DISPLAY PANEL": "Pedia-Lax Sodium Phosphates Saline Enema 2.25 fl oz (66 mL)", "Keep out of reach of children": "If swallowed, get medical help or contact a Poison Control Center right away.", "Ask a doctor before using this product if the child": "is on a sodium-restricted diet", "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"}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:04:41.327627 · Updated: 2026-03-14T23:05:37.016425