Fleet Enema
FDA Label NDC 0132-0201

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 0132-0201). 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 118-ml delivered dose), use, warnings, ask a doctor before using this product if you, stop use and consult a doctor if you have, keep out of reach of children, if pregnant or breast-feeding, directions, 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)

Monobasic Sodium Phosphate 19 g.................Saline Laxative

Dibasic Sodium Phosphate 7 g........................Saline Laxative

Use

For relief of occasional constipation.

Warnings

For rectal use only.

Dosage warning: Using more then one enema in 24 hours can be harmful.

Do not use without asking a doctor:

  • for more than 3 days
  • if you have kidney disease
  • if you have heart problems
  • if you are dehydrated

Ask A Doctor Before Using This Product If You

  • are 55 years of age or older
  • are on a sodium-restricted diet


    • 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 Consult 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 or urinating less often than normal)

    • 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.

If Pregnant Or Breast-Feeding

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

Directions

Single Daily Dosage (per 24 hours).


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

Other Information

  • each 118-mL delivered dose contains: sodium 4.4 g
  • additional liquids by mouth are recommended while taking this product
  • this product usually produces a bowel movement in 1-5 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 Reference Safety Information on our website

Inactive Ingredients

benzalkonium chloride, disodium EDTA, purified water

Questions?

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

Fleet Enema Principle Display Panel

Fleet Enema Carton (Fleetenemacarton)

Fleet Enema Carton (Fleetenemacarton)

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