fleet saline enema extra 0132-0078

SPL v1

SPL

SPL Set ID f50ba829-16c3-40a7-9822-8d6d00353b33

Route

rectal

Published

Effective Date 2024-02-29

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

sodium cation (7 g) phosphate ion (19 g)

Inactive Ingredients

edetate disodium water benzalkonium chloride

Identifiers & Packaging

Marketing Status

otc monograph drug active Since 2004-06-25

Purpose

(in each 197 mL delivered dose) Monobasic sodium phosphate 19g ... Saline laxative Dibasic sodium phosphate 7g ......... Saline laxative

Description

Drug Facts

Medication Information

Warnings

For rectal use only.

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

Purpose

(in each 197 mL delivered dose)

Monobasic sodium phosphate 19g ... Saline laxative

Dibasic sodium phosphate 7g ......... Saline laxative

Directions

Single Daily Dosage (per 24 hours).

Do not use if taking another sodium phosphates product. Do not use more unless directed by a

doctor. See Warnings .

adults and children 12 and over	1 bottle per day
children 2 to 11 years	use Fleet® Pedia-Lax® Enema
children under 2 years	DO NOT USE

If no urge is felt after 5 minutes of using, try to empty bowel. Call a doctor promptly if no liquid comes out of the rectum after 30 minutes because dehydration could occur.

Other Information

• each 197 mL delivered dose contains: sodium 4.4 g

• additional liquids by mouth are recommended while taking this product

Inactive Ingredients

benzalkonium chloride, disodium EDTA, purified water

Description

Drug Facts

Principal Display Panel

Fleet

Laxative

Saline

Enema

Extra Volume

1 Bottle 7.8 Fl Oz (230 mL) each

Questions?

1-866-255-6960 or www.fleetlabs.com

Use

for relief of occasional constipation. This product usually produces a bowel movement in 1 to 5 minutes.

Section 42229-5

Drug Facts

Do Not Use

• for more than 3 days

• if you have kidney disease

• if you have heart problems

• if you are dehydrated

• when abdominal pain, nausea, or vomiting are present unless directed by a doctor

Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Stop Use and Ask A Doctor If You Have

• rectal bleeding

• no bowel movement or no liquid comes out of the rectum after 30 minutes

• symptoms of dehydration [feeling thirsty, dizziness, vomiting, urinating less often than normal]

These symptoms may indicate a serious condition.

Ask A Doctor Before Using This Product If You

• are 55 years of age or older

• are on a sodium-restricted diet

• have 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.

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

Purpose

(in each 197 mL delivered dose)

Monobasic sodium phosphate 19g ... Saline laxative

Dibasic sodium phosphate 7g ......... Saline laxative

Directions

Single Daily Dosage (per 24 hours).

Do not use if taking another sodium phosphates product. Do not use more unless directed by a

doctor. See Warnings .

adults and children 12 and over	1 bottle per day
children 2 to 11 years	use Fleet® Pedia-Lax® Enema
children under 2 years	DO NOT USE

If no urge is felt after 5 minutes of using, try to empty bowel. Call a doctor promptly if no liquid comes out of the rectum after 30 minutes because dehydration could occur.

Other Information (Other information)

• each 197 mL delivered dose contains: sodium 4.4 g

• additional liquids by mouth are recommended while taking this product

Inactive Ingredients (Inactive ingredients)

benzalkonium chloride, disodium EDTA, purified water

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Fleet

Laxative

Saline

Enema

Extra Volume

1 Bottle 7.8 Fl Oz (230 mL) each

Questions?

1-866-255-6960 or www.fleetlabs.com

Use

for relief of occasional constipation. This product usually produces a bowel movement in 1 to 5 minutes.

Section 42229-5 (42229-5)

Drug Facts

Do Not Use (Do not use)

• for more than 3 days

• if you have kidney disease

• if you have heart problems

• if you are dehydrated

• when abdominal pain, nausea, or vomiting are present unless directed by a doctor

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

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Stop Use and Ask A Doctor If You Have (Stop use and ask a doctor if you have)

• rectal bleeding

• no bowel movement or no liquid comes out of the rectum after 30 minutes

• symptoms of dehydration [feeling thirsty, dizziness, vomiting, urinating less often than normal]

These symptoms may indicate a serious condition.

Ask A Doctor Before Using This Product If You (Ask a doctor before using this product if you)

• are 55 years of age or older

• are on a sodium-restricted diet

• have 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": "7", "strengthDenominator": "230", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "PHOSPHATE ION", "unii": "NK08V8K8HR", "classCode": "ACTIB", "strengthNumerator": "19", "strengthDenominator": "230", "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. This product usually produces a bowel movement in 1 to 5 minutes.", "42229-5": "Drug Facts", "Purpose": "(in each 197 mL delivered dose) Monobasic sodium phosphate 19g ... Saline laxative Dibasic sodium phosphate 7g ......... Saline laxative", "Warnings": "For rectal use only. Using more than one enema in 24 hours can be harmful.", "Directions": "Single Daily Dosage (per 24 hours). Do not use if taking another sodium phosphates product. Do not use more unless directed by a doctor. See Warnings . adults and children 12 and over 1 bottle per day children 2 to 11 years use Fleet® Pedia-Lax® Enema children under 2 years DO NOT USE If no urge is felt after 5 minutes of using, try to empty bowel. Call a doctor promptly if no liquid comes out of the rectum after 30 minutes because dehydration could occur.", "Do not use": "• for more than 3 days • if you have kidney disease • if you have heart problems • if you are dehydrated • when abdominal pain, nausea, or vomiting are present unless directed by a doctor", "Questions?": "1-866-255-6960 or www.fleetlabs.com", "Other information": "• each 197 mL delivered dose contains: sodium 4.4 g • additional liquids by mouth are recommended while taking this product", "Inactive ingredients": "benzalkonium chloride, disodium EDTA, purified water", "PRINCIPAL DISPLAY PANEL": "Fleet Laxative Saline Enema Extra Volume 1 Bottle 7.8 Fl Oz (230 mL) each", "Keep out of reach of children.": "If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.", "Stop use and ask a doctor if you have": "• rectal bleeding • no bowel movement or no liquid comes out of the rectum after 30 minutes • symptoms of dehydration [feeling thirsty, dizziness, vomiting, urinating less often than normal] These symptoms may indicate a serious condition.", "Ask a doctor before using this product if you": "• are 55 years of age or older • are on a sodium-restricted diet • have a sudden change in bowel habits lasting more than 2 weeks • already used a laxative for more than 1 week"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:49.134177 · Updated: 2026-03-14T23:02:34.788055