Principal Display Panel

Principal Display Panel
SPL v16
SPL
SPL Set ID 40a29169-dd77-43b1-8887-b91cf98107c6
Route
ORAL
Published
Effective Date 2025-04-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Identifiers & Packaging


Description

Bisacodyl USP, 5 mg


Medication Information

Indications and Usage

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

Dosage and Administration

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

Description

Bisacodyl USP, 5 mg

Section 44425-7

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

Section 50565-1

In case of overdose, get medical help or contact a Poison Control Center right away.

Section 50566-9

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

Section 50567-7

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

Section 50569-3

stomach pain, nausea or vomiting a sudden change in bowel habits that lasts more than 2 weeks

Section 50570-1

if you cannot swallow without chewing.

Section 51727-6

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

Section 51945-4

sunmark® COMPARE TO DULCOLAX® LAXATIVE TABLETS ACTIVE INGREDIENT* NDC 49348-032-05 gentle laxative BISACODYL USP, 5 mg stimulant laxative gentle, dependable constipation relief COMFORT COATED ACTUAL SIZE 25 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 Sanofi-Aventis Deutschland GMBH, owner of the registered trademark Dulcolax® Laxative Tablets. 50844    REV0119B32756 Distributed by McKesson Corp., via Strategic Sourcing Services LLC, Memphis, TN 38141 © 2003 McKesson Corporation www.sunmarkbrand.com Money Back Guarantee Sunmark 44-327

Section 53413-1

1-800-426-9391

Section 53414-9

ask a health professional before use.

Section 55105-1

Stimulant laxative

Section 55106-9

Bisacodyl USP, 5 mg


Structured Label Content

Indications and Usage (34067-9)

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

Dosage and Administration (34068-7)

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

Section 44425-7 (44425-7)

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

Section 50565-1 (50565-1)

In case of overdose, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

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

Section 50567-7 (50567-7)

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

Section 50569-3 (50569-3)

stomach pain, nausea or vomiting a sudden change in bowel habits that lasts more than 2 weeks

Section 50570-1 (50570-1)

if you cannot swallow without chewing.

Section 51727-6 (51727-6)

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

Section 51945-4 (51945-4)

sunmark® COMPARE TO DULCOLAX® LAXATIVE TABLETS ACTIVE INGREDIENT* NDC 49348-032-05 gentle laxative BISACODYL USP, 5 mg stimulant laxative gentle, dependable constipation relief COMFORT COATED ACTUAL SIZE 25 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 Sanofi-Aventis Deutschland GMBH, owner of the registered trademark Dulcolax® Laxative Tablets. 50844    REV0119B32756 Distributed by McKesson Corp., via Strategic Sourcing Services LLC, Memphis, TN 38141 © 2003 McKesson Corporation www.sunmarkbrand.com Money Back Guarantee Sunmark 44-327

Section 53413-1 (53413-1)

1-800-426-9391

Section 53414-9 (53414-9)

ask a health professional before use.

Section 55105-1 (55105-1)

Stimulant laxative

Section 55106-9 (55106-9)

Bisacodyl USP, 5 mg


Raw Label Data

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