Womens Gentle Laxative

Manufacturer
FRED'S, INC. | LNK International, Inc.
Effective date
2020-06-11
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
legacy-cache
Hydrated at
2026-08-01 23:26:29

Label at a glance#

ProductWomens Gentle Laxative
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

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

Storage and handling

TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN avoid excessive humidity 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 USP, 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 cannot swallow without chewing. 

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

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

When using this product

OTC - WHEN USING SECTION

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

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • 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,

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

  • 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

STORAGE AND HANDLING SECTION

  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
  • avoid excessive humidity
  • 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

carmine, colloidal silicon dioxide, corn starch, FD&C red #40 aluminum lake, hypromellose, lactose anhydrous, magnesium stearate, methacrylic acid, microcrystalline cellulose, 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

freds®
Pharmacy

NDC 55315-676-01

Women's
Gentle Laxative

Bisacodyl USP, 5 mg / Stimulant Laxative

Gentle, Predictable Overnight Relief

Actual Size

30 COMFORT COATED
TABLETS

50844        ORG041867601

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

DISTRIBUTED BY: fred's, Inc.
4300 NEW GETWELL RD, MEMPHIS, TN 38118
www.fredsinc.com

100%
Satisfaction
guaranteed

Questions or comments:
1-855-331-FRED (3733)

Freds 44-676A
Freds 44-676A

Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55315-67655315-676-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

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
9c1c6c6c-6dca-4c97-9476-df43db1c35023787977d-e68c-4720-a05c-b5fc8ca67b5b2020-06-11WarningsExact identifier
spl id: 9c1c6c6c-6dca-4c97-9476-df43db1c3502
spl set id: 3787977d-e68c-4720-a05c-b5fc8ca67b5b

Reported adverse events (FAERS/openFDA)#

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