Dulcolax
FDA Label NDC 29485-6741

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Mechanical Servants, Inc. for the product Dulcolax (NDC 29485-6741). 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 other, active ingredient (in each tablet), purpose, use, otc - do not use, ask a doctor before use if you have, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Repackaged and distributed by Convenience Valet® Melrose Park, IL 60160

Active Ingredient (In Each Tablet)

Bisacodyl USP 5 mg

Purpose

Stimulant laxative

Use

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

Otc - Do Not Use

Do not use if you cannot swallow without chewing

Ask A Doctor Before Use If You Have

  • stomach 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
  • it may cause stomach discomfort, faintness and cramps

Stop Use And Ask A Doctor If

  • you have rectal bleeding or no bowel movement after using this product. These could be signs of a serious condition.
  • you need to use a laxative for more than 1 week

Otc - Pregnancy Or Breast Feeding

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

Otc - Keep Out Of Reach Of Children

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 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 at 20-25°C (68-77°F)
  • protect from excessive humidity

Inactive Ingredients

acacia, acetylated monoglyceride, carnauba wax, cellulose acetate phthalate, corn starch, dibutyl phthalate, docusate sodium, gelatin, glycerin, iron oxides, kaolin, lactose, magnesium stearate, methylparaben, pharmaceutical glaze, polyethylene glycol, povidone, propylparaben, Red No. 30 lake, sodium benzoate, sorbitan monooleate, sucrose, talc, titanium dioxide, white wax, Yellow No. 10 lake

Questions

1-888-285-9159 (English/Spanish)

Or visit www.DULCOLAX.com

Principal Display Panel - 5 Mg Pouch Package

CONVENIENCE
CV
VALET®

DRINKING CUP
INCLUDED

Dulcolax®
LAXATIVE
(bisacodyl USP 5 mg)
C6A

3 TABLETS

Principal Display Panel (5 mg Pouch Package)

Principal Display Panel (5 mg Pouch Package)

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