Gentle Laxative Tablet, Delayed Release
FDA Label NDC 55910-327

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Dolgencorp, Llc for the product Gentle Laxative (NDC 55910-327). 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)

→ 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,

→ Keep Out Of Reach Of Children.

→ Directions

→ Other Information

→ Inactive Ingredients

→ Principal Display Panel

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

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

When Using This Product

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

Stop Use And Ask A Doctor If

you have rectal bleeding or fail to have a bowel movement after use of a laxative. These could be signs of 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 (1-800-222-1222) right away.

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 of age	take 1 tablet in a single daily dose
children under 6 years	ask a doctor

Other Information

TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
store at 25°C (77°F); excursions permitted between15°-30°C (59°-86°F)
avoid excessive humidity
see end flap for expiration date and lot number

Inactive Ingredients

acacia, ammonium hydroxide, calcium carbonate, carnauba wax, colloidal anhydrous silica, corn starch, D&C yellow #10 aluminum lake, FD&C yellow #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