Active Ingredient (In Each Tablet)
Bisacodyl 5 mg
Gentle Laxative Tablet, Delayed Release
FDA Label NDC 50844-327
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by L.n.k. International, Inc. for the product Gentle Laxative (NDC 50844-327). 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
- relieves 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
- 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
- you may have stomach discomfort, faintness or 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
- 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 of age | take 1 tablet in a single daily dose |
| children under 6 years of age | ask a doctor |
Other Information
- 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, corn starch, D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, iron oxide black, lactose, magnesium stearate, methylparaben, polydextrose, polyethylene glycol, polyvinyl acetate phthalate, povidone, propylene glycol, propylparaben, shellac, silica,simethicone, sodium alginate, sodium benzoate, sodium bicarbonate, stearic acid, sucrose, talc, titanium dioxide, triacetin, triethyl citrate
Questions Or Comments?
1-800-426-9391
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QUALITY
+ PLUS
NDC 50844-327-15
*Compare to active ingredient in Dulcolax® Laxative Tablets
GENTLE
LAXATIVE
Bisacodyl 5 mg
STIMULANT LAXATIVE
Gentle, predictable overnight relief
50 Tablets COMFORT COATED ACTUAL SIZE
TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING
*This product is not manufactured or distributed by Boehringer Ingelheim Pharmaceuticals, Inc., owner of the registered trademark Dulcolax® Laxative Tablets.
50844 ORG031232715
Distributed by
LNK INTERNATIONAL, INC.
60 Arkay Drive
Hauppauge, NY 11788
USA
Quality Plus 44-327 (Quality Plus 44 327 1)
* Please review the disclaimer below.
