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

Warnings


Active Ingredient
Bisacodyl 5 mg

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

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


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

  • Protect from excessive humidity
Description

Bisacodyl 5 mg

Questions?

Adverse drug event call: (866) 562-2756

Section 51945-4
Section 55105-1
Stimulant laxative

Do Not Use
if you cannot swallow without chewing

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.

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

Warnings


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

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

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


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

  • Protect from excessive humidity
Questions?

Adverse drug event call: (866) 562-2756

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

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

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.

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