bisacodyl tablets

bisacodyl tablets
SPL v6
SPL
SPL Set ID 9b379dbe-f2b1-4c9d-8651-d7ade79230bd
Route
oral
Published
Effective Date 2020-07-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
deacetylbisacodyl (5 mg)
Inactive Ingredients
acacia calcium sulfate anhydrous anhydrous lactose carnauba wax silicon dioxide starch, corn d&c yellow no. 10 fd&c yellow no. 6 gelatin ferric oxide red ferric oxide yellow ferrosoferric oxide magnesium stearate microcrystalline cellulose polyethylene glycol 400 polyvinyl acetate phthalate povidone k30 shellac sodium starch glycolate type a corn stearic acid talc titanium dioxide sucrose

Identifiers & Packaging

Pill Appearance
Imprint: TCL003 Shape: round Color: orange Size: 5 mm Score: 1
Marketing Status
otc monograph drug active Since 2020-07-06
Purpose

Stimulant laxative

Description

Bisacodyl (USP) 5 mg

Medication Information

Warnings

Do not use if you cannot swallow without chewing

Active Ingredient

Bisacodyl (USP) 5 mg

Uses
  • for temporary relief of occasional constipation and irregularity
  • this product generally produces bowel movement in 6 to 12 hours
Purpose

Stimulant laxative

Dosage and Administration

Directions

  • take with a glass of water
 adults and children 12 years and over  1 to 3 tablets in a single daily dose
 children 6 to under 12 years of age  1 tablet in a single daily dose
 children under 6 years of age  ask a doctor

Inactive Ingredients

Acacia, anhydrous calcium sulfate, anhydrous lactose,

carnauba wax, colloidal silicon dioxide, corn starch, D&C

Yellow #10 Aluminum Lake, FD&C Yellow #6 Aluminum

Lake, gelatin, iron oxide, iron oxide black, iron oxide yellow

(iron oxide ochre), magnesium stearate, microcrystalline

cellulose, polyethylene glycol (PEG) 400, polyvinyl acetate

phthalate, povidone, shellac, sodium starch glycolate, stearic

acid, sugar, talc, titanium dioxide

Description

Bisacodyl (USP) 5 mg

Principal Display Panel

CABINET

Bisacodyl Tablets,

USP 5 mg

Section 50565-1

Keep out of reach of children.

Section 53413-1

Questions or comments? 1-888-333-9792

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Section 60561-8

Other information

■ each tablet contains: magnesium 5 mg

■ store at 20-25°C (68-77°F)

■ protect from excessive humidity

When Using This Product

■ do not chew or crush tablet(s)

■ it may cause stomach discomfort, faintness and cramps

■ do not use within 1 hour after taking an antacid or milk

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

Ask A Doctor Before Use If You Have

■ stomach pain, nausea or vomiting

■ a sudden change in bowel habits that lasts more than 2

weeks

Structured Label Content

Warnings

Do not use if you cannot swallow without chewing

Active Ingredient (Active ingredient (in each tablet))

Bisacodyl (USP) 5 mg

Uses
  • for temporary relief of occasional constipation and irregularity
  • this product generally produces bowel movement in 6 to 12 hours
Purpose

Stimulant laxative

Dosage and Administration (34068-7)

Directions

  • take with a glass of water
 adults and children 12 years and over  1 to 3 tablets in a single daily dose
 children 6 to under 12 years of age  1 tablet in a single daily dose
 children under 6 years of age  ask a doctor

Inactive Ingredients (Inactive ingredients)

Acacia, anhydrous calcium sulfate, anhydrous lactose,

carnauba wax, colloidal silicon dioxide, corn starch, D&C

Yellow #10 Aluminum Lake, FD&C Yellow #6 Aluminum

Lake, gelatin, iron oxide, iron oxide black, iron oxide yellow

(iron oxide ochre), magnesium stearate, microcrystalline

cellulose, polyethylene glycol (PEG) 400, polyvinyl acetate

phthalate, povidone, shellac, sodium starch glycolate, stearic

acid, sugar, talc, titanium dioxide

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

CABINET

Bisacodyl Tablets,

USP 5 mg

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 53413-1 (53413-1)

Questions or comments? 1-888-333-9792

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Section 60561-8 (60561-8)

Other information

■ each tablet contains: magnesium 5 mg

■ store at 20-25°C (68-77°F)

■ protect from excessive humidity

When Using This Product (When using this product)

■ do not chew or crush tablet(s)

■ it may cause stomach discomfort, faintness and cramps

■ do not use within 1 hour after taking an antacid or milk

Stop Use and Ask A Doctor If (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

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

■ stomach pain, nausea or vomiting

■ a sudden change in bowel habits that lasts more than 2

weeks

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:04:44.452927 · Updated: 2026-03-14T23:05:38.431426