Fleet Enema
FDA Label NDC 0132-0703

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 0132-0703). 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 (in each 30-ml delivered dose), use, 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 30-Ml Delivered Dose)

Bisacodyl 10 mg, Stimulant Laxative / Bowel Cleanser

Use

Use for relief of occasional constipation or bowel cleansing before rectal examinations

Warnings

For rectal use only

This product may cause abdominal discomfort, faintness, rectal burning, and mild cramps

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

Stop Use And Ask A Doctor If You Have

  • rectal bleeding
  • no bowel movement within 20 minutes of enema use

    • These symptoms may indicate a serious condition.

Keep Out Of Reach Of Children

Keept 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 Dosage (per 24 hours)

 adults and children 12 years and over 1 bottle per day
 children under 12 years DO NOT USE

Other Information

  • this product generally produces a bowel movement in 5-20 minutes
  • store at temperatures not above 86F (30C)
  • For complete professional use warnings and precautions, consult the Reference Safety Information on our website
  • BOTTLE SEALED FOR SAFETY. IF BOTTLE WRAPPER WITH FLEET EMBLEM IS TORN, DAMAGED OR MISSING, DO NOT USE

Inactive Ingredients

carbomer 934P, glycerin, methylparaben, octoxynol-9, propylparaben, purified water, sodium hydroxide

Questions?

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

Package Label.Principal Display Panel

Fleet Bisacodyl Enema Carton (Fleetbisacodylenemacarton)

Fleet Bisacodyl Enema Carton (Fleetbisacodylenemacarton)

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