Active Ingredient (In Each Tablet)
Bisacodyl USP, 5 mg
Gentle Laxative Tablet, Delayed Release
FDA Label NDC 53943-677
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Discount Drug Mart for the product Gentle Laxative (NDC 53943-677). 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 cannot swallow without chewing.
Ask A Doctor Before Use If You Have
- a sudden change in bowel habits that lasts more than 2 weeks
- stomach pain, nausea or vomiting
When Using This Product
- do not chew or crush tablet(s)
- do not use within 1 hour after taking an antacid or milk
- it may cause 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 right away.
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 |
Other Information
- TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
- avoid excessive humidity
- 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
carmine, colloidal silicon dioxide, corn starch, FD&C red #40 aluminum lake, hypromellose, lactose anhydrous, magnesium stearate, methacrylic acid, microcrystalline cellulose, polydextrose, polyethylene glycol, shellac wax, simethicone, sodium bicarbonate, sodium lauryl sulfate, stearic acid, talc, titanium dioxide, triacetin, triethyl citrate
Questions Or Comments?
1-800-426-9391
Principal Display Panel
NDC 53943-677-01
DISCOUNT
drug
mart
FOOD MARKET
AN EMPLOYEE OWNERSHIP COMPANY
Gentle Laxative
Bisacodyl USP, 5 mg Stimulant Laxative
Gentle, dependable
constipation relief
30 Tablets
MAY CONTAIN
ANTI-THEFT
DEVICE
Actual Size
Comfort Coated
Tablets
DISTRIBUTED BY:
DRUG MART - FOOD FAIR
211 COMMERCE DRIVE,
MEDINA, OH 44256
www.discount-drugmart.com
SATISFACTION GUARANTEED
IF DISSATISFIED, RETURN UNUSED PORTION AND PACKAGE
TO STORE WHERE PURCHASED. IF UNABLE TO RETURN TO
STORE, SEND REASON FOR DISSATISFACTION, NAME,
ADDRESS AND EMPTY PACKAGE TO:
DISCOUNT DRUG MART
211 COMMERCE DRIVE, MEDINA, OHIO 44256
TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER
UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING
Discount Drug Mart 44-676a (Drug Mart 44 676a Gentle 1)
* Please review the disclaimer below.
