Fleet Tablet, Coated
FDA Label NDC 0132-0401

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 0132-0401). 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 tablet), purpose, uses, do not use, ask a doctor before use if you have, when using this product, stop use and ask a doctor if, if pregnant or breast-feeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient (In Each Tablet)

Bisacodyl USP 5 mg

Purpose

Stimulant laxative

Uses

  • for temporary relief of occasional constipation and irregularity
  • this product generally produces bowel movement in 6 to 12 hours

Do Not Use

if you cannot swallow without chewing

Ask A Doctor Before Use If You Have

  • abdominal pain, nausea or vomiting
  • a sudden change in bowel habits that lasts more than 2 weeks

When Using This Product

  • do not chew or crush tablet(s)
  • do not use within 1 hour after taking an antacid or milk
  • you may have stomach discomfort, faintness and cramps

Stop Use And Ask A Doctor If

  • you have rectal bleeding or no bowel movement after use of a laxative 

    • These symptoms may indicate a serious condition.

    • you need to use a laxative for more than 1 week

If Pregnant Or Breast-Feeding,

ask a health professional before use.

Keep Out Of Reach Of Children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

  • Take with a glass of water
    • Adults and children 12 years of age and over1 to 3 tablets in a single daily dose
    Children 6 to under 12 years of age1 tablet in a single daily dose
    Children under 6 years of ageask a doctor

Other Information

  • store between 68° to 77°F (20° to 25°C)

    • Tamper Evident: Do not use if blister unit is broken or torn

Inactive Ingredients

acacia, ammonium hydroxide, calcium carbonate, carnauba wax, colloidal anhydrous silica, corn starch, D&C yellow no. 10 aluminum lake, FD&C yellow no. 6 aluminum lake, hypromellose, iron oxide black, lactose anhydrous, magnesium stearate, methylparaben, polydextrose, polyethylene glycol, polyvinyl acetate phthalate, povidone, propylene glycol, propylparaben, shellac glaze, simethicone, sodium alginate, sodium benzoate, sodium bicarbonate, stearic acid, sucrose, talc, titanium dioxide, triacetin, triethyl citrate

Questions?

Call 1-866-255-6960

Principal Display Panel

Fleet

Bisacodyl 5 mg Stimulant

stimulant

oral laxative

25 coated tablets

Principal Display Panel Fleet Bisacodyl 5 mg Stimulantstimulantoral Laxative25 Coated Tablets (Fleet Oral Lax Bisacodyl 0132 0401 01)

Principal Display Panel Fleet Bisacodyl 5 mg Stimulantstimulantoral Laxative25 Coated Tablets (Fleet Oral Lax Bisacodyl 0132 0401 01)

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