Topcare 44-327

Topcare 44-327
SPL v10
SPL
SPL Set ID e4ff1277-b859-4c34-872f-0dc5b7879121
Route
ORAL
Published
Effective Date 2026-03-10
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 2019-05-15
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)
  • see end flap for expiration date and lot number
  • avoid excessive humidity
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?

1-888-423-0139

Principal Display Panel

+TopCare® 

health

NDC 36800-327-03

COMPARE TO

DULCOLAX® LAXATIVE

TABLETS ACTIVE

INGREDIENT*

Gentle

Laxative

BISACODYL USP 5 mg • STIMULANT LAXATIVE

Gentle, Dependable

Constipation Relief

10 COMFORT COATED

TABLETS 

actual

size

TAMPER EVIDENT: DO NOT USE IF

PACKAGE IS OPENED OR IF BLISTER

UNIT IS TORN, BROKEN OR SHOWS

ANY SIGNS OF TAMPERING

DISTRIBUTED BY TOPCO ASSOCIATES LLC

ITASCA, IL 60143

©TOPCO LNKA0823

QUESTIONS? 1-888-423-0139

[email protected]

www.topcarebrand.com

QUALITY GUARANTEED

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

owner of the registered trademark Dulcolax® Laxative Tablets.

50844         REV0923B32703

TopCare 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)
  • see end flap for expiration date and lot number
  • avoid excessive humidity
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?)

1-888-423-0139

Principal Display Panel

+TopCare® 

health

NDC 36800-327-03

COMPARE TO

DULCOLAX® LAXATIVE

TABLETS ACTIVE

INGREDIENT*

Gentle

Laxative

BISACODYL USP 5 mg • STIMULANT LAXATIVE

Gentle, Dependable

Constipation Relief

10 COMFORT COATED

TABLETS 

actual

size

TAMPER EVIDENT: DO NOT USE IF

PACKAGE IS OPENED OR IF BLISTER

UNIT IS TORN, BROKEN OR SHOWS

ANY SIGNS OF TAMPERING

DISTRIBUTED BY TOPCO ASSOCIATES LLC

ITASCA, IL 60143

©TOPCO LNKA0823

QUESTIONS? 1-888-423-0139

[email protected]

www.topcarebrand.com

QUALITY GUARANTEED

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

owner of the registered trademark Dulcolax® Laxative Tablets.

50844         REV0923B32703

TopCare 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)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:46.844018 · Updated: 2026-03-14T23:14:12.168159