fleet saline enema 0132-0201

fleet saline enema 0132-0201
SPL v12
SPL
SPL Set ID c1677d70-203b-493e-88f0-815a66133f1d
Route
rectal
Published
Effective Date 2025-11-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
sodium cation (7 g)
Inactive Ingredients
edetate disodium water benzalkonium chloride

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 1953-03-10

Purpose

Saline laxative Saline laxative

Description

Monobasic Sodium Phosphate 19 g................ Dibasic Sodium Phosphate 7 g........................


Medication Information

Warnings

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

For rectal use only.

Purpose

Saline laxative

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 years and over     1 bottle per day

children 2 to 11 yearsuse Fleet® Pedia-Lax® Enema

children under 2 yearsDO 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 118 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

Monobasic Sodium Phosphate 19 g................ Dibasic Sodium Phosphate 7 g........................

Principal Display Panel

Fleet ®

Laxative

Saline Enema

1 Bottle 4.5 Fl Oz (133 mL)

Questions?

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

Tamper Evident: Bottle sealed for safety. If bottle wrapper with Fleet® emblem is torn, damaged or missing, do not use.

Use

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

Stop
  • 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.

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
Ask A Doctor Before Using
  • 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  
Active Ingredient (in Each 118

Monobasic Sodium Phosphate 19 g................

Dibasic Sodium Phosphate 7 g........................

If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out of Reach of Children.

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


Structured Label Content

Warnings

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

For rectal use only.

Purpose

Saline laxative

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 years and over     1 bottle per day

children 2 to 11 yearsuse Fleet® Pedia-Lax® Enema

children under 2 yearsDO 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 118 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 (PRINCIPAL DISPLAY PANEL)

Fleet ®

Laxative

Saline Enema

1 Bottle 4.5 Fl Oz (133 mL)

Questions?

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

Tamper Evident: Bottle sealed for safety. If bottle wrapper with Fleet® emblem is torn, damaged or missing, do not use.

Use

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

Stop
  • 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.

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
Ask A Doctor Before Using (Ask a doctor before using)
  • 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  
Active Ingredient (in Each 118 (Active Ingredient (in each 118)

Monobasic Sodium Phosphate 19 g................

Dibasic Sodium Phosphate 7 g........................

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

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.


Advanced Ingredient Data


Raw Label Data

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