SPL v1
SPL
SPL Set ID 017bc27d-a951-48a4-8f65-90fcbe6dbea0
Route
ORAL
Published
Effective Date 2025-05-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Deacetylbisacodyl (5 mg)
Inactive Ingredients
Sodium Alginate Sodium Benzoate Sodium Bicarbonate Stearic Acid Sucrose Talc Titanium Dioxide Triacetin Triethyl Citrate Acacia Ammonia Calcium Carbonate Carnauba Wax Starch, Corn D&c Yellow No. 10 Fd&c Yellow No. 6 Hypromelloses Ferrosoferric Oxide Lactose Monohydrate Magnesium Stearate Methylparaben Polydextrose Polyethylene Glycol, Unspecified Polyvinyl Acetate Phthalate Propylparaben Propylene Glycol Povidone Shellac Dimethicone Silicon Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: 5 Shape: round Color: orange Size: 6 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-07-01

Description

Bisacodyl 5 mg

Purpose

Stimulant Laxative


Medication Information

Purpose

Stimulant Laxative

Description

Bisacodyl 5 mg

Uses
  • for relief of occasional constipation and irregularity
  • this product generally produces bowel movement in 6 to 12 hours
Section 42229-5

Manufactured for:

SDA Laboratories, Inc.

New York, NY

Section 50565-1

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Warnings

Do not useif 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 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.

Directions
  • take with a glass of water
  • do not take more than directed
  • 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
  • store at controlled room temperature 20°-25°C (68°-77°F); excursions permitted between 15º-30ºC (59º-86ºF)
  • avoid excessive humidity
  • package not child resistant
Inactive Ingredients

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?

1-203-861-0005

Principal Display Panel

Active Ingredient (in Each Tablet)

Bisacodyl 5 mg


Structured Label Content

Uses
  • for relief of occasional constipation and irregularity
  • this product generally produces bowel movement in 6 to 12 hours
Section 42229-5 (42229-5)

Manufactured for:

SDA Laboratories, Inc.

New York, NY

Section 50565-1 (50565-1)

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Purpose

Stimulant Laxative

Warnings

Do not useif 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 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.

Directions
  • take with a glass of water
  • do not take more than directed
  • 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 (Other information)
  • store at controlled room temperature 20°-25°C (68°-77°F); excursions permitted between 15º-30ºC (59º-86ºF)
  • avoid excessive humidity
  • package not child resistant
Inactive Ingredients (Inactive ingredients)

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? (Questions or comments?)

1-203-861-0005

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))

Bisacodyl 5 mg


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)