Active Ingredient (In Each Tablet)
Bisacodyl 5 mg
Laxative Tablet, Delayed Release
FDA Label NDC 67091-286
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Winco Foods, Llc for the product Laxative (NDC 67091-286). 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 (irregularity)
- this product generally produces bowel movement in 6 to 12 hours
Do Not Use
if you are unable to swallow without chewing.
Ask A Doctor Before Use If You Have
- abdominal pain
- nausea
- vomiting
- noticed a sudden change in bowel habits that persists over a period of 2 weeks
When Using This Product
- abdominal discomfort, faintness, and cramps may occur
- do not use for a period longer than 1 week unless directed by a doctor
Stop Use And Ask A Doctor If
rectal bleeding or failure to have a bowel movement occurs after use of a laxative. These may 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 (1-800-222-1222) right away.
Directions
- do not chew or crush tablets
- do not take within 1 hour after taking an antacid or milk
- take with water
- adults and children 12 years and over: take 1 to 3 tablets in a single dose, once daily
- children under 12 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)
- see end flap for expiration date and lot number
Inactive Ingredients
anhydrous lactose, carmine, colloidal silicon dioxide, corn starch, FD&C red #40 aluminum lake, hypromellose, magnesium stearate, methacrylic acid, polydextrose, polyethylene glycol, shellac wax, simethicone, sodium bicarbonate, sodium lauryl sulfate, stearic acid, talc, titanium dioxide, triacetin, triethyl citrate
Questions?
Or to report a side effect call 800-824-1706 Monday - Friday 9 am - 4pm MST
Principal Display Panel
*Compare to the active ingredient
in CORRECTOL®
Gentle, Overnight Relief
WinCo™
FOODS
WOMEN'S
Laxative
BISACODYL 5 mg/
STIMULANT LAXATIVE
30
Enteric Coated
Tablets
TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT
IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING
DISTRIBUTED BY:
WINCO FOODS, LLC, BOISE, ID 83704
*This product is not manufactured or distributed by
BAYER HEALTHCARE LLC, distributor of CORRECTOL®.
100% SATISFACTION GUARANTEE
Comments & Questions? 800-824-1706
50844
ORG051567601
WF1408
Winco 44-676 (Winco 44 676 1)
* Please review the disclaimer below.
