Active Ingredient (In Each Tablet)
Bisacodyl USP, 5 mg
Bisacodyl Laxative Tablet, Delayed Release
FDA Label NDC 50804-327
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Geiss, Destin & Dunn Inc. for the product Bisacodyl Laxative (NDC 50804-327). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient (in each tablet), purpose, uses, do not use, ask a doctor before use if you have, when using this product, stop use and ask a doctor if, if pregnant or breast-feeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Stimulant laxative
Uses
- for relief of occasional constipation and irregularity
- this product generally produces bowel movement in 6 to 12 hours
Do Not Use
if you cannot swallow without chewing.
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
When Using This Product
- do not use within 1 hour after taking an antacid or milk
- do not chew or crush tablet(s)
- you may have 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.
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 |
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 the active ingredient
in 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 Sanofi-Aventis Deutschland
GMBH, owner of the registered trademark
Dulcolax® Laxative Tablets.
50844 ORG011932756
Distributed by:
Geiss, Destin & Dunn, Inc., A Perrigo Company
Peachtree City, GA 30269
www.PerrigoDirect.com (1-800-426-9391)
GoodSense® is a registered trademark of
L. Perrigo Company.
Goodsense 44-327 (Goodsense 44 327 1)
* Please review the disclaimer below.
