Womens Gentle Laxative: Package Insert and Label Information

WOMENS GENTLE LAXATIVE- bisacodyl tablet, delayed release
DOLGENCORP, INC.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Active Ingredient (in each softgel)

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

Warnings

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

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

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 1(800)222-1222

Directions

• take with a glass of water

adults and children 12 years and over	1 to 3 tablets in a single daily dose
children 6 to under 12 years of age	1 tablet in a single daily dose
children under 6 years of age	ask a doctor

Other Information

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

Inactive ingredien ts

dextrose monohydrate, D&C Red #27, FD&C Blue #1, hypromellose, lactose monohydrate, lecithin, magnesium stearate, maltodextrin, methacrylic acid copolymer, methyl cellulose, pregelatinized starch, silica, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triacetin, triethyl citrate

Questions or comments?

1-888-333-9792

PRINCIPAL DISPLAY PANEL

Compare to the active ingredient in Dulcolax® Pink® Laxative Tablets*

Women’s Gentle Laxative
Bisacodyl USP 5 mg

• stimulant laxative
• gentle, overnight relief

25 tablets

WOMENS GENTLE LAXATIVE bisacodyl tablet, delayed release

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55910-850 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BISACODYL (DEACETYLBISACODYL) BISACODYL 25 mg

Inactive Ingredients Ingredient Name Strength HYPROMELLOSES LACTOSE MONOHYDRATE LECITHIN, SOYBEAN MAGNESIUM STEARATE MALTODEXTRIN AMMONIUM ACRYLOYL DIMETHYLTAURATE/METHACRYLATE, DIMETHYLACRYLAMIDE AND METHACRYLIC ACID COPOLYMER, PPG-3 GLYCERYL TRIACRYLATE CROSSLINKED (100000 MW) HYDROXYMETHYL CELLULOSE STARCH, POTATO SILICA DIMETHYL SILYLATE SODIUM BICARBONATE SODIUM LAURYL SULFATE TALC TITANIUM DIOXIDE TRIACETIN TRIETHYL CITRATE DEXTROSE MONOHYDRATE D&C RED NO. 27 FD&C BLUE NO. 1

Product Characteristics Color pink Score no score Shape ROUND Size 6mm Flavor Imprint Code F Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:55910-850-25 25 TABLET, DELAYED RELEASE in 1 BLISTER PACK None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 05/14/2022

Labeler — DOLGENCORP, INC. (068331990)

Revised: 11/2022 DOLGENCORP, INC.