Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID c96e2eff-bd7e-4019-9826-c15bafe2e406
Route
ORAL
Published
Effective Date 2013-12-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Bisacodyl (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 Ferrosoferric Oxide Ferric Oxide Yellow Magnesium Stearate Cellulose, Microcrystalline Polyethylene Glycol 400 Polyvinyl Acetate Phthalate Povidones Shellac Sodium Starch Glycolate Type A Potato Stearic Acid Sucrose Talc Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: TCL;003 Shape: round Color: orange Size: 6 mm Score: 1
Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2011-09-22
Description

Active ingredient (in each tablet) Bisacodyl 5 mg

Medication Information

Warnings and Precautions

Warnings

Indications and Usage

Uses

  • relieves occasional constipation
  • generally produces bowel movement in 6-12 hours
Dosage and Administration

Directions

DO NOT CHEW TABLETS

adults and children 12 years and over: 1-3 tablets once daily

children 6 to 11 years: 1 tablet once daily

children under 6 years: ask a doctor



Description

Active ingredient (in each tablet) Bisacodyl 5 mg

Section 44425-7

Other information

store at 20°-25°C (68°-77°F)

Section 50565-1

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

Section 50566-9

Stop use and ask a doctor if

  • you have rectal bleeding
  • you fail to have a bowel movement after use of this product

These may indicate a serious condition.

Section 50567-7

When using this product

  • do not take dose within one hour of taking an antacid or milk
  • you may experience abdominal discomfort, faintness and cramps
Section 50568-5

Ask a doctor or pharmacist before use if you are taking any other drug. Take this product two or more hours before or after other drugs. Laxatives may affect how other drugs work.

Section 50569-3

Ask a doctor before use if you have noticed a sudden change in bowel habits that lasts over two weeks

Section 50570-1

Do not use

  • for longer than one week
  • when abdominal pain, nausea or vomiting are present
  • in children under 6 years of age
  • in persons who cannot swallow without chewing
Section 51727-6

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

Section 51945-4
Section 53413-1

Questions or comments?

call 1-800-645-2158 9 am - 5 pm ET, Monday - Friday

Repackaged By :

Aidarex Pharmaceuticals LLC,

Corona, CA 92880

Section 53414-9

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

Section 55105-1

Purpose

Laxative

Section 55106-9

Active ingredient (in each tablet)

Bisacodyl 5 mg

Structured Label Content

Indications and Usage (34067-9)

Uses

  • relieves occasional constipation
  • generally produces bowel movement in 6-12 hours
Dosage and Administration (34068-7)

Directions

DO NOT CHEW TABLETS

adults and children 12 years and over: 1-3 tablets once daily

children 6 to 11 years: 1 tablet once daily

children under 6 years: ask a doctor



Warnings and Precautions (34071-1)

Warnings

Section 44425-7 (44425-7)

Other information

store at 20°-25°C (68°-77°F)

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.

Section 50566-9 (50566-9)

Stop use and ask a doctor if

  • you have rectal bleeding
  • you fail to have a bowel movement after use of this product

These may indicate a serious condition.

Section 50567-7 (50567-7)

When using this product

  • do not take dose within one hour of taking an antacid or milk
  • you may experience abdominal discomfort, faintness and cramps
Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are taking any other drug. Take this product two or more hours before or after other drugs. Laxatives may affect how other drugs work.

Section 50569-3 (50569-3)

Ask a doctor before use if you have noticed a sudden change in bowel habits that lasts over two weeks

Section 50570-1 (50570-1)

Do not use

  • for longer than one week
  • when abdominal pain, nausea or vomiting are present
  • in children under 6 years of age
  • in persons who cannot swallow without chewing
Section 51727-6 (51727-6)

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

Section 51945-4 (51945-4)
Section 53413-1 (53413-1)

Questions or comments?

call 1-800-645-2158 9 am - 5 pm ET, Monday - Friday

Repackaged By :

Aidarex Pharmaceuticals LLC,

Corona, CA 92880

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Purpose

Laxative

Section 55106-9 (55106-9)

Active ingredient (in each tablet)

Bisacodyl 5 mg

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:43.948762 · Updated: 2026-03-14T22:53:39.434183