Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 29156c82-bb48-4356-860c-ca0e9001882e
Route
ORAL
Published
Effective Date 2012-06-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Bisacodyl (5 mg)
Inactive Ingredients
Acacia Anhydrous Lactose Yellow Wax Calcium Sulfate Carnauba Wax Silicon Dioxide Starch, Corn D&c Yellow No. 10 Fd&c Yellow No. 6 Gelatin Ferrosoferric Oxide Magnesium Stearate Cellulose, Microcrystalline Shellac Polyvinyl Acetate Phthalate Povidone K30 Sodium Starch Glycolate Type A Potato Stearic Acid Sucrose Talc Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: S1 Shape: round Color: orange Size: 6 mm Score: 1
Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2006-01-25
Description

Bisacodyl 5 mg

Medication Information

Indications and Usage
  • For temporary relief of occasional constipation and irregularity
  • This product generally produces bowel movement in 6 to 12 hours

Description

Bisacodyl 5 mg

Section 51945-4
Section 55105-1
Stimulant laxative

Warnings


Directions
Take with a glass of water



adults and children 12 years of age 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


Do Not Use
if you cannot swallow without chewing

Questions?

Adverse drug event call: (866) 562-2756

Other Information
  • Store at 20 - 250C (68-770F)

  • 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

If Pregnant Or Breast Feeding,
ask a health professional before use.

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

Active Ingredient (in Each Tablet)
Bisacodyl 5 mg

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

Inactive Ingredients: Acacia, Anhydrous Lactose, Beeswax, Calcium Sulfate, Carnauba Wax, Colloidal Silicon Dioxide, Corn Starch, D&c Yellow #10 Lake, Edible Ink, Fd&c Yellow #6 Lake, Gelatin, Iron Oxide Black, Magnesium Stearate, Microcrystalline Cellulose, Pharmaceutical Glaze, Polyvinyl Acetate Phthalate, Povidone, Sodium Starch Glycolate, Stearic Acid, Sugar, Titanium Dioxide


Structured Label Content

Indications and Usage (34067-9)
  • For temporary relief of occasional constipation and irregularity
  • This product generally produces bowel movement in 6 to 12 hours

Section 51945-4 (51945-4)
Section 55105-1 (55105-1)
Stimulant laxative

Warnings


Directions
Take with a glass of water



adults and children 12 years of age 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


Do Not Use (Do not use)
if you cannot swallow without chewing

Questions?

Adverse drug event call: (866) 562-2756

Other Information (Other information)
  • Store at 20 - 250C (68-770F)

  • 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

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)
ask a health professional before use.

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

Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))
Bisacodyl 5 mg

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

Inactive Ingredients: Acacia, Anhydrous Lactose, Beeswax, Calcium Sulfate, Carnauba Wax, Colloidal Silicon Dioxide, Corn Starch, D&c Yellow #10 Lake, Edible Ink, Fd&c Yellow #6 Lake, Gelatin, Iron Oxide Black, Magnesium Stearate, Microcrystalline Cellulose, Pharmaceutical Glaze, Polyvinyl Acetate Phthalate, Povidone, Sodium Starch Glycolate, Stearic Acid, Sugar, Titanium Dioxide (Inactive ingredients: acacia, anhydrous lactose, beeswax, calcium sulfate, carnauba wax, colloidal silicon dioxide, corn starch, D&C yellow #10 lake, edible ink, FD&C yellow #6 lake, gelatin, iron oxide black, magnesium stearate, microcrystalline cellulose, pharmaceutical glaze, polyvinyl acetate phthalate, povidone, sodium starch glycolate, stearic acid, sugar, titanium dioxide)


Advanced Ingredient Data

Raw Label Data

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Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:29.188960 · Updated: 2026-03-14T22:53:10.919261