Active Ingredient (In Each Tablet)
Bisacodyl USP, 5 mg
Bisacodyl Tablet, Delayed Release
FDA Label NDC 0904-6748
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Major Pharmaceuticals for the product Bisacodyl (NDC 0904-6748). 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 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.
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
- store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
- avoid excessive humidity
- use by expiration date on package
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
Principal Display Panel
NDC 0904-6748-60
Major®
Bisacodyl
USP, 5 mg TABLETS
Stimulant Laxative
For Temporary Relief of
Occasional Constipation
ENTERIC COATED
Compare to the active
ingredient in DULCOLAX®
Laxative Tablets*
Actual Size
100 TABLETS
TAMPER EVIDENT: DO NOT USE IF
IMPRINTED SAFETY SEAL UNDER
CAP IS BROKEN OR MISSING
*This product is not manufactured or distributed by Sanofi-Aventis
Deutschland GMBH, owner of the registered trademark Dulcolax®
Laxative Tablets. 50844 REV0119A32712
Distributed by MAJOR® PHARMACEUTICALS
17177 N Laurel Park Drive, Suite 233
Livonia, MI 48152 USA M-17 Rev. 03/19 Re-order No. 700928
Major 44-327 (Major 44 327 1)
* Please review the disclaimer below.
