Active Ingredient (In Each Tablet)
Bisacodyl, USP 5 mg
Gentle Laxative Tablet, Coated
FDA Label NDC 63868-908
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Quality Choice (chain Drug Marketing Association) for the product Gentle Laxative (NDC 63868-908). 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, use, do not use, ask a doctor before use if you have, when using this product, stop use and ask a doctor if, if pregnancy 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
Use
- for temporary relief of occasional constipation and irregularity
- this product generally produces a 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
- it may cause stomach discomfort, faintness and cramps
Stop Use And Ask A Doctor If
- you have rectal bleeding or no bowel movement after using this product. These could be signs of a serious condition.
- you need to use a laxative for more than 1 week
If Pregnancy 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. (1-800-222-1222).
Directions
take with a glass of water
adults and children 12 years of age 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 20-25°C (68°-77°F)
- Protect from excessive humidity
Inactive Ingredients
acacia, anhydrous calcium sulfate, anhydrous lactose, carnauba wax, colloidal silicon dioxide, corn starch, D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, gelatin, iron oxide, iron oxide black, iron oxide yellow, magnesium stearate, microcrystalline cellulose, polyethylene glycol (PEG) 400, polyvinyl acetate phthalate, povidone, shellac, sodium starch glycolate, stearic acid, sugar, talc, titanium dioxide.
Questions Or Comments?
1-866-467-2748
Principal Display Panel
NDC# 63868-908-25
*Compare to the Active Ingredient in Dulcolax®
Gentle Laxative
Relieves Constipation & Irregularity
Bisacodyl, USP 5 mg
Relieves Constipation And Irregularity Overnight
Comfort-Coated Tablets For Gentle, Predictable Constipation Relief
25 TABLETS
100% QC SATISFACTION GURANTEED
*This product is not manufactured or distributed by Boehringer Ingelheim Pharmaceuticals, Inc., the owner of the registered trademark Dulcolax®.
TAMPER EVIDENT: DO NOT USE IF any individual unit is broken or open.
Distributed by C.D.M.A., Inc.
43157 W. Nine Mile
Novi, MI 48376-0995
Questions: 248-449-9300
Product Label
QC(CDMA) Gentle Laxative
* Please review the disclaimer below.
