Fleet Enema
FDA Label NDC 0132-0301

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 0132-0301). 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 active ingredient, uses, warnings, ask a doctor before using any laxative if you have, stop use and ask a doctor if you have, keep out of reach of children, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

(in each 118-mL delivered dose)

Mineral Oil 100%, Lubricant Laxative

Uses

  • for relief of fecal impaction
  • for relief of occasional constipation
  • for removal of residue after barium administration

Warnings

For rectal use only

If pregnant or breast-feeding ask a health professional before use.

Ask A Doctor Before Using Any Laxative If You Have

  • 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
  • If constipation continues after one week of use, contact your doctor

Stop Use And Ask A Doctor If You Have

  • rectal bleeding
  • no bowel movement within 15 minutes of using this product

    • These symptoms may indicate a serious condition.

Keep Out Of Reach Of Children

Keep out of reach of children to prevent accidental ingestion.


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

Directions

Single daily dose

 adults and children 12 years and over 1 bottle per day
 children 2 to under 12 years one-half bottle
 children under 2 yearsDO NOT USE

Other Information

  • sodium free
  • this product generally produces a bowel movement in 2-15 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

Questions?

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

* Please review the disclaimer below.