Gentle Laxative Tablet, Delayed Release
FDA Label NDC 79903-178

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Wal-mart Stores Inc for the product Gentle Laxative (NDC 79903-178). 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 otc - active ingredient, purpose, indications & usage, warnings, otc - ask doctor, otc - when using, otc - stop use, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active ingredient                 

(In each tablet)

  Bisacodyl 5mg

Purpose

Stimulant Laxative

Indications & Usage

Uses

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

Warnings

Do not use if you cannot swallow without chewing

Otc - Ask Doctor

Ask a doctor before use if you have

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

Otc - When Using

When using this product

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

Otc - Stop Use

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 1(800) 222-1222.

Directions

  • take with a glass of water
  • adults and children 12 years and over: take 1 to 3 tablets in a single daily dose
  • children 6 to under 12 years: take 1 tablet in a single daily dose
  • children under 6 years: ask a doctor

Other Information

  • each tablet contains: magnesium 5 mg
  • store at 25°C (77°F) , excursions permitted between 15-30°C (59-86°F)
  • protect from excessive humidity

Inactive Ingredients

acacia, carnauba wax, collodial silicon dioxide, corn starch, FD&C yellow #6, lactose anhydrous, magnesium stearate, methacrylic acid,
microcrystalline cellulose, polyvinyl acetate, shellac, sodium starch glycoale, stearic acid, talc, titanium dioxide, triacetin

Questions Or Comments?

1-888-287-1915

Other

Distributed by:
Walmart Inc.
Bentonville, AR 72716

Product of India

*This product is not manufactured or distributed by Boehringer Ingelheim Pharmaceuticals, Inc., distributor of Dulcolax® Laxative.

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Compare to Dulcolax® Laxative active ingredient*


GENTLE LAXATIVE

BISACODYL 5 mg

  • Overnight Relief
  • Gentle, dependable constipation relief
  • Relief in 6-12 hours


    • 8 TABLETS

    ENTERIC COATED

* Please review the disclaimer below.