Active Ingredient(S)
Bisacodyl 5mg
Bisacodyl
FDA Label NDC 67544-655
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Aphena Pharma Solutions - Tennessee, Llc for the product Bisacodyl (NDC 67544-655). 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, when using this product, stop use and ask a doctor if, pregnancy/breastfeeding, 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)
-relieves occasional constipation and irregularity
-this product generally produces bowel movement in 6 to 12 hours
Do Not Use
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 use within 1 hour after taking an antacid or milk
-do not chew or crush tablet(s)
-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
Pregnancy/Breastfeeding
ask a health professions before use.
Keep Out Of Reach Of Children
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
Repackaged by Aphena Pharma Solutions - TN. |
 Aphena Pharma Solutions (TN) |
Storage
-store at 25 degrees C (77 degrees F) excursions permitted between 15 degrees-30 degrees C (59 degrees-86 degrees F)
-use by expiration date on package
-protect from excessive humidity
Inactive Ingredients
acacia, bees wax, calcium sulfate, carnauba wax, cellulose, corn starch, D&C Yellow No. 10 lake, FD&C Yellow No. 6 lake, gelatin, lactose, magnesium stearate, pharmaceutical glaze, polyvinyl acetate phthalate, silica gel, sodium starch glycolate, stearinc acid, sugar, talc, titanium dioxide.
Questions
To Report Adverse Drug Event call: (800) 616-2471
Repackaging Information
Please reference the Product Characteristics section listed below for a description of individual tablets or capsules. This drug product has been received by Aphena Pharma - TN in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from Aphena are listed below:
| Count | 4mg |
| 04 | 67544-655-04 |
| 06 | 67544-655-06 |
Store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature. Dispense in a tight light-resistant container as defined by USP. Keep this and all drugs out of the reach of children.
Repackaged by:
Aphena Pharma Solutions (TN)
Cookeville, TN 38506
20130612AW
Principal Display Panel - 5Mg
NDC 67544-655 - Bisacodyl 5mg
Bottle Label 5mg (67544 655)
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