Active Ingredient(S)
Bisacodyl USP 5 mg
The Medicine Shoppe Gentle Laxative
FDA Label NDC 49614-131
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by The Medicine Shoppe International for the product The Medicine Shoppe Gentle Laxative (NDC 49614-131). 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(s), purpose, use(s), 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
Use(S)
- for temporary 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)
- it may cause stomach discomfort, faintness or cramps
- do not use within 1 hour after taking an antacid or milk
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 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
- each tablet contains: sodium less than 0.5mg
- store at 20°-25°C (68°-77°F)
- protect from excessive humidity
- TAMPER EVIDENT: Blister packaged for your protection. Do not use if individual seals are broken
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.
Principal Display Panel
The Medicine Shoppe
Gentle Laxative
Overnight Relief of Constipation and Irregularity
*Compare to the active ingredient of Dulcolax®
LAXATIVE
Bisacodyl USP, 5 mg
25 Coated Tablets
CIN 1796986
Distributed By:
The Medicine Shoppe International, Inc.
Earth City MO 63045
www.medicineshoppe.com
A Cardinal Health Company
Questions? 1-800-325-1397
Medicine Shoppe Gentle Laxative 25ct (22cdf899 52f4 417f 93e4 A42881bd11cf 01)
* Please review the disclaimer below.
