Purpose
(in each 197 mL delivered dose)
Monobasic sodium phosphate 19g ... Saline laxative
Dibasic sodium phosphate 7g ......... Saline laxative
Fleet Enema
FDA Label NDC 0132-0078
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by C.b. Fleet Company, Inc. for the product Fleet (NDC 0132-0078). 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 purpose, use, warnings, do not use, ask a doctor before using this product if you, stop use and ask a doctor if you have, keep out of reach of children., directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Use
for relief of occasional constipation. This product usually produces a bowel movement in 1 to 5 minutes.
Warnings
For rectal use only.
Using more than one enema in 24 hours can be harmful.
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 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
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.
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
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
Questions?
1-866-255-6960 or www.fleetlabs.com
Principal Display Panel
Fleet
Laxative
Saline
Enema
Extra Volume
1 Bottle 7.8 Fl Oz (230 mL) each
Principal Display Panelfleetlaxativesalineenemaextra Volume1 Bottle 7.8 Fl Oz (230 mL) Each (Fleet Saline Enema Extra 0132 0078 01)
* Please review the disclaimer below.
