FDA.reportPublic FDA data

Gentle Laxative

Manufacturer
L&R Distributors, Inc. | LNK International, Inc.
Effective date
2019-05-08
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-02 00:24:27

Label at a glance#

ProductGentle Laxative Womens
Active ingredientBISACODYL
Label structure9 sections

Indications and uses

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

Dosage and administration

do not chew or crush tablets do not take within 1 hour after taking an antacid or milk take with water adults and children 12 years and over: take 1 to 3 tablets in a single dose, once daily children under 12 years: ask a doctor 

Storage and handling

TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF) see end flap for expiration date and lot number 

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Bisacodyl 5 mg 

Purpose

OTC - PURPOSE SECTION

Stimulant laxative 

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

if you are unable to swallow without chewing. 

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • abdominal pain
  • nausea
  • vomiting
  • noticed a sudden change in bowel habits that persists over a period of 2 weeks

When using this product

OTC - WHEN USING SECTION

  • abdominal discomfort, faintness, and cramps may occur
  • do not use for a period longer than 1 week unless directed by a doctor

Stop use and ask a doctor if

OTC - STOP USE SECTION

rectal bleeding or failure to have a bowel movement occurs after use of a laxative. These may be signs of a serious condition. 

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use. 

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. 

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not chew or crush tablets
  • do not take within 1 hour after taking an antacid or milk
  • take with water
  • adults and children 12 years and over: take 1 to 3 tablets in a single dose, once daily
  • children under 12 years: ask a doctor 

Other information

STORAGE AND HANDLING SECTION

  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • see end flap for expiration date and lot number 

Inactive ingredients

INACTIVE INGREDIENT SECTION

anhydrous lactose, carmine, colloidal silicon dioxide, corn starch, FD&C red #40 aluminum lake, hypromellose, magnesium stearate, methacrylic acid, polydextrose, polyethylene glycol, shellac wax, simethicone, sodium bicarbonate, sodium lauryl sulfate, stearic acid, talc, titanium dioxide, triacetin, triethyl citrate 

Questions or comments?

OTC - QUESTIONS SECTION

1-800-426-9391 

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

select brand®
the lower price name brand

NDC 15127-676-01

Women's
G e n t l e   L a x a t i v e

Bisacodyl 5 mg • Stimulant Laxative

Gentle, Dependable
Overnight Relief

*Compare to the Active Ingredient of Correctol®

30 TABLETS

Actual Size

ENTERIC COATED

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF
BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

*This product is not manufactured or distributed by
Bayer HealthCare LLC, owner of the registered trademark
Correctol®.         50844            ORG051567601

Distributed by:
SELECT BRAND® DISTRIBUTORS
Pine Bluff, AR 71603   USA
AC (870) 535-3635 

Select Brand 44-676
Select Brand 44-676

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
15127-67615127-676-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Name, UNII, Kind table
NameUNIIKind
BISACODYL10X0709Y6IACTIB
STARCH, CORNO8232NY3SJIACT
FD&C RED NO. 40WZB9127XOAIACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
MAGNESIUM STEARATE70097M6I30IACT
METHACRYLIC ACID1CS02G8656IACT
POLYDEXTROSEVH2XOU12IEIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
SHELLAC46N107B71OIACT
SODIUM BICARBONATE8MDF5V39QOIACT
ANHYDROUS LACTOSE3SY5LH9PMKIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
SODIUM LAURYL SULFATE368GB5141JIACT
STEARIC ACID4ELV7Z65APIACT
TALC7SEV7J4R1UIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
TRIACETINXHX3C3X673IACT
TRIETHYL CITRATE8Z96QXD6UMIACT
DIMETHICONE92RU3N3Y1OIACT
WATER059QF0KO0RIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
c4ae7c1e-7739-4500-bd62-e0e7a59dfee57f3bfdef-768c-4b82-8f03-0a3d842d43a92019-05-08WarningsExact identifier
spl id: c4ae7c1e-7739-4500-bd62-e0e7a59dfee5
spl set id: 7f3bfdef-768c-4b82-8f03-0a3d842d43a9

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.