Bisacodyl

Manufacturer
RELIABLE 1 LABORATORIES LLC | Geri-Care Pharmaceutical Corp
Effective date
2023-10-23
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 21:23:23

Label at a glance#

ProductBisacodyl
Active ingredientBISACODYL
Label structure9 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 older: take 1 to 3 tablets in a single daily dose children 12 and under: ask a doctor

Storage and handling

Tamper Evident: Do not use if imprinted seal under cap is missing or broken store at room temperature15°-30°C (59°-86°F) avoid excessive humidity package not child resistant

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 and irregularity
  • this product generally produces bowel movement in 6 to 12 hours

Warnings

WARNINGS SECTION

Do not use if you cannot swallow without chewing.

Ask a doctor before use if you have

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

When using this product

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

Stop use and ask a doctor

  • 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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. 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 older: take 1 to 3 tablets in a single daily dose
  • children 12 and under: ask a doctor

Other information

STORAGE AND HANDLING SECTION

  • Tamper Evident: Do not use if imprinted seal under cap is missing or broken
  • store at room temperature15°-30°C (59°-86°F)
  • avoid excessive humidity
  • package not child resistant

Inactive ingredients

INACTIVE INGREDIENT SECTION

Acacia, Ammonium Hydroxide,
Calcium Carbonate, Corn Starch, D&C Yellow #10 Lake,
FD&C Yellow #6 Lake, Hypromellose, Iron Oxide Black,
Lactose, Magnesium Stearate, Methylparaben, PEG,
Polydextrose, Polyvinyl Acetate Phthalate, Propylparaben,
Propylene Glycol, Povidone, Shellac, Simethicone, Silica,
Sodium Alginate, Sodium Benzoate, Sodium Bicarbonate,
Stearic Acid, Sucrose, Talc, Titanium Dioxide, Triacetin,
Triethyl Citrate, Wax.

Questions or comments?

OTC - QUESTIONS SECTION

call 516-341-0666,
8:30 am - 4:30 pm ET, Monday - Friday

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

Products#

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

DailyMed product names page 1 of 1 · 32 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69618-05869618-058-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 31 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
0864ecf0-4b0f-715e-e063-6294a90a1778b60c85d7-5eb1-aab9-e053-2a95a90a43612023-10-23WarningsExact identifier
spl id: 0864ecf0-4b0f-715e-e063-6294a90a1778
spl set id: b60c85d7-5eb1-aab9-e053-2a95a90a4361

Reported adverse events (FAERS/openFDA)#

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