Goodsense 44-327

Goodsense 44-327
SPL v8
SPL
SPL Set ID 165de5d4-58a6-4117-bca6-8a186da25e00
Route
ORAL
Published
Effective Date 2025-11-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Deacetylbisacodyl (5 mg)
Inactive Ingredients
Acacia Ammonia Calcium Carbonate Carnauba Wax Silicon Dioxide Starch, Corn D&c Yellow No. 10 Aluminum Lake Fd&c Yellow No. 6 Aluminum Lake Hypromellose, Unspecified Ferrosoferric Oxide Anhydrous Lactose Magnesium Stearate Methylparaben Polydextrose Polyethylene Glycol, Unspecified Polyvinyl Acetate Phthalate Povidone, Unspecified 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 DRUG Active Since 2021-04-29

Description

Bisacodyl USP, 5 mg

Purpose

Stimulant laxative


Medication Information

Purpose

Stimulant laxative

Description

Bisacodyl USP, 5 mg

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

Directions
  • do not take more than directed
  • 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?

1-800-426-9391

Principal Display Panel

GOODSENSE®

NDC 50804-327-56

Dependable Relief

Bisacodyl

Laxative

Bisacodyl USP 5 mg

Stimulant Laxative

Gentle, Dependable

Constipation Relief

25 Enteric Coated Tablets

(5 mg Each)

actual size

*Compare to active ingredient of

Dulcolax® Laxative Tablets

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER

UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

*This product is not manufactured or distributed by A. Nattermann & Cie. GmbH,

owner of the registered trademark Dulcolax® Laxative Tablets.

50844         REV0923B32756

Distributed by:

Perrigo Direct, Inc.

Peachtree City, GA 30269

www.PerrigoDirect.com

(1-800-426-9391)

GoodSense® is a registered trademark

of L. Perrigo Company.

Good Sense 44-327
When Using This Product
  • do not use within 1 hour after taking an antacid or milk
  • do not chew or crush tablet(s)
  • it may cause stomach discomfort, faintness, and cramps
Stop Use and Ask A Doctor If
  • you need to use a laxative for more than 1 week
  • you have rectal bleeding or fail to have a bowel movement after use of a laxative. These could be signs of a serious condition.

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

Purpose

Stimulant laxative

Directions
  • do not take more than directed
  • 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?)

1-800-426-9391

Principal Display Panel (Principal display panel)

GOODSENSE®

NDC 50804-327-56

Dependable Relief

Bisacodyl

Laxative

Bisacodyl USP 5 mg

Stimulant Laxative

Gentle, Dependable

Constipation Relief

25 Enteric Coated Tablets

(5 mg Each)

actual size

*Compare to active ingredient of

Dulcolax® Laxative Tablets

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER

UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

*This product is not manufactured or distributed by A. Nattermann & Cie. GmbH,

owner of the registered trademark Dulcolax® Laxative Tablets.

50844         REV0923B32756

Distributed by:

Perrigo Direct, Inc.

Peachtree City, GA 30269

www.PerrigoDirect.com

(1-800-426-9391)

GoodSense® is a registered trademark

of L. Perrigo Company.

Good Sense 44-327
When Using This Product (When using this product)
  • do not use within 1 hour after taking an antacid or milk
  • do not chew or crush tablet(s)
  • it may cause stomach discomfort, faintness, and cramps
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • you need to use a laxative for more than 1 week
  • you have rectal bleeding or fail to have a bowel movement after use of a laxative. These could be signs of a serious condition.

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 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)