Major 44-327

Major 44-327
SPL v2
SPL
SPL Set ID b5e1a7f8-17ef-4d67-aeea-879603f800a5
Route
ORAL
Published
Effective Date 2019-08-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Deacetylbisacodyl (5 mg)
Inactive Ingredients
Acacia Calcium Carbonate Carnauba Wax Silicon Dioxide Starch, Corn D&c Yellow No. 10 Fd&c Yellow No. 6 Hypromellose, Unspecified Ferrosoferric Oxide Anhydrous Lactose Magnesium Stearate Methylparaben Polydextrose Polyethylene Glycol, Unspecified Polyvinyl Acetate Phthalate Povidone Propylene Glycol Propylparaben Shellac Dimethicone Water Sodium Alginate Sodium Benzoate Sodium Bicarbonate Stearic Acid Sucrose Talc Titanium Dioxide Triacetin Triethyl Citrate

Identifiers & Packaging

Pill Appearance
Imprint: 5 Shape: round Color: orange Size: 6 mm Score: 1
Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2018-12-01
Description

Bisacodyl USP, 5 mg

Purpose

Stimulant laxative

Medication Information

Purpose

Stimulant laxative

Description

Bisacodyl USP, 5 mg

Uses
  • 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 and over		 take 1 to 3 tablets

in a single daily dose 
children 6 to under

12 years		 take 1 tablet in a single

daily dose
children under 6 years ask a doctor


Do Not Use

if you cannot swallow without chewing.

Other Information
  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
  •  store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)

  • avoid excessive humidity

  • see end flap for expiration date and lot number



Inactive Ingredients

acacia, ammonium hydroxide, calcium carbonate, carnauba wax, colloidal anhydrous silica, corn starch, D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake,

hypromellose, iron oxide black, lactose anhydrous, magnesium stearate, methylparaben, polydextrose, polyethylene glycol, polyvinyl acetate phthalate, povidone, propylene glycol, propylparaben, shellac

glaze, simethicone, sodium alginate, sodium benzoate, sodium bicarbonate, stearic acid, sucrose, talc, titanium dioxide, triacetin, triethyl citrate

Questions Or Comments?

(800)-616-2471

Repackaging Information

Please reference the How Supplied section listed above for a description of individual tablets. This drug product has been received by Aphena Pharma - TN in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from Aphena are listed below:

Count 5 mg
4 71610-219-04

Store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature. Dispense in a tight light-resistant container as defined by USP. Keep this and all drugs out of the reach of children.

Repackaged by:



Cookeville, TN 38506



20190801JH

When Using This Product
  • do not chew or crush tablet(s)

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

  • you may have stomach discomfort, faintness and cramps

Stop Use and Ask A Doctor If
  • you have rectal bleeding or fail to have a bowel movement after use of a laxative. 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.

Principal Display Panel 5 Mg

NDC 71610-219 - Bisacodyl EC, USP 5 mg

Active Ingredient (in Each Tablet)

Bisacodyl USP, 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

Structured Label Content

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

Stimulant laxative

Directions
  • take with a glass of water
adults and children

12 years and over		 take 1 to 3 tablets

in a single daily dose 
children 6 to under

12 years		 take 1 tablet in a single

daily dose
children under 6 years ask a doctor


Do Not Use (Do not use)

if you cannot swallow without chewing.

Other Information (Other information)
  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
  •  store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)

  • avoid excessive humidity

  • see end flap for expiration date and lot number



Inactive Ingredients (Inactive ingredients)

acacia, ammonium hydroxide, calcium carbonate, carnauba wax, colloidal anhydrous silica, corn starch, D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake,

hypromellose, iron oxide black, lactose anhydrous, magnesium stearate, methylparaben, polydextrose, polyethylene glycol, polyvinyl acetate phthalate, povidone, propylene glycol, propylparaben, shellac

glaze, simethicone, sodium alginate, sodium benzoate, sodium bicarbonate, stearic acid, sucrose, talc, titanium dioxide, triacetin, triethyl citrate

Questions Or Comments? (Questions or comments?)

(800)-616-2471

Repackaging Information

Please reference the How Supplied section listed above for a description of individual tablets. This drug product has been received by Aphena Pharma - TN in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from Aphena are listed below:

Count 5 mg
4 71610-219-04

Store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature. Dispense in a tight light-resistant container as defined by USP. Keep this and all drugs out of the reach of children.

Repackaged by:



Cookeville, TN 38506



20190801JH

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

  • you may have 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 use of a laxative. 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.

Principal Display Panel 5 Mg (PRINCIPAL DISPLAY PANEL - 5 mg)

NDC 71610-219 - Bisacodyl EC, USP 5 mg

Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))

Bisacodyl USP, 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

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:51.007268 · Updated: 2026-03-14T22:55:35.679907