afb39544-c509-490c-ad42-ba68ebbf986b

SPL v1
SPL
SPL Set ID afb39544-c509-490c-ad42-ba68ebbf986b
Route
oral
Published
Effective Date 2025-07-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
deacetylbisacodyl (5 mg)
Inactive Ingredients
silicon dioxide hypromellose 2910 (5 mpa.s) magnesium stearate maltodextrin methacrylic acid microcrystalline cellulose d&c yellow no. 10 aluminum lake fd&c yellow no. 6 aluminum lake polyethylene glycol 400 sodium starch glycolate type a talc titanium dioxide triethyl citrate

Identifiers & Packaging

Pill Appearance
Imprint: B5 Shape: round Color: orange Size: 6 mm Score: 1
Marketing Status
otc monograph drug active Since 2025-07-28

Purpose

Laxative

Description

Bisacodyl USP, 5 mg


Medication Information

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

Laxative

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

Other Information
  • store at controlled room temperature 20°-25°C (68°-77°F)
  • read all product information before use.
Inactive Ingredients

Colloidal silicon dioxide, hypromellose-5, magnesium stearate, maltodextrin, methacrylic acid, microcrystalline cellulose, neelicert FD&C yellow 10 Al Lake, neelicert FD&C yellow 6 Al Lake, PEG 400, sodium starch glycolate, talc, titanium dioxide, triethyl citrate.

Description

Bisacodyl USP, 5 mg

Principal Display Panel

Do Not Use

if you cannot swallow without chewing

Questions Or Comments?

Call + 1-848-235-5293

Monday through Friday 9AM – 5PM EST

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 fail to have a 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 (1-800-222-1222) 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

Structured Label Content

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

Laxative

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

Other Information (Other information)
  • store at controlled room temperature 20°-25°C (68°-77°F)
  • read all product information before use.
Inactive Ingredients (Inactive ingredients)

Colloidal silicon dioxide, hypromellose-5, magnesium stearate, maltodextrin, methacrylic acid, microcrystalline cellulose, neelicert FD&C yellow 10 Al Lake, neelicert FD&C yellow 6 Al Lake, PEG 400, sodium starch glycolate, talc, titanium dioxide, triethyl citrate.

Principal Display Panel

Do Not Use (Do not use)

if you cannot swallow without chewing

Questions Or Comments? (Questions or comments?)

Call + 1-848-235-5293

Monday through Friday 9AM – 5PM EST

When Using This Product (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 (Stop use and ask a doctor if)
  • you have rectal bleeding or fail to have a 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 (1-800-222-1222) 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

Advanced Ingredient Data


Raw Label Data

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