gentle laxative

Manufacturer
Bryant Ranch Prepack
Effective date
2024-04-05
Label type
HUMAN OTC DRUG LABEL
Version
102
Source
legacy-cache
Hydrated at
2026-08-01 21:03:59

Label at a glance#

Productgentle laxative
Active ingredientBISACODYL
Label structure10 sections

Indications and uses

for relief of occasional constipation and 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 store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) avoid excessive humidity 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 and 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

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

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 right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • take with a glass of water
adults and children 12 years and overtake 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 yearsask 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 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • avoid excessive humidity
  • see end flap for expiration date and lot number

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

1-800-426-9391

HOW SUPPLIED

How Supplied Section

NDC: 71335-1754-0: 25 Tablets in a BLISTER PACK

NDC: 71335-1754-1: 30 Tablets in a BLISTER PACK

NDC: 71335-1754-2: 2 Tablets in a BLISTER PACK

NDC: 71335-1754-3: 3 Tablets in a BLISTER PACK

NDC: 71335-1754-4: 4 Tablets in a BLISTER PACK

NDC: 71335-1754-5: 10 Tablets in a BLISTER PACK

NDC: 71335-1754-6: 90 Tablets in a BLISTER PACK

NDC: 71335-1754-7: 8 Tablets in a BLISTER PACK

NDC: 71335-1754-8: 100 Tablets in a BLISTER PACK

NDC: 71335-1754-9: 20 Tablets in a BLISTER PACK

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bisacodyl 5mg Tablet

Label
Label

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49348-032-05EA - Each49348-0324e529213-9481-4bee-be5b-d201bae6c8df12016-07-19
49348-032-10EA - Each49348-032cf435827-18e6-4e3a-889a-945988f6820512016-07-19

Products#

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

DailyMed product names page 1 of 1 · 34 matching rows.

NDC Codes#

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 32 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
12e5e85e-bb89-41c6-ad00-115bd135692b20b705fd-de43-4745-b15f-8ce7e90a37ba2024-04-05WarningsExact identifier
spl id: 12e5e85e-bb89-41c6-ad00-115bd135692b
spl set id: 20b705fd-de43-4745-b15f-8ce7e90a37ba

Reported adverse events (FAERS/openFDA)#

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