FDA Label for Gentle Laxative
View Indications, Usage & Precautions
Gentle Laxative Product Label
The following document was submitted to the FDA by the labeler of this product Cardinal Health. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient(S)
Bisacodyl 5 mg
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.
Questions
Call 1-800-200-6313, weekdays, 9am-4pm EST
Principal Display Panel
The product packaging shown below represents a sample of that currently in use. Additional packaging may also be available.
TABLETS
Leader Gentle Laxative
Overnight Relief of Constipation and Irregularity
*Compare to the active ingredient of Dulcolax®
LAXATIVE
Bisacodyl USP, 5 mg
25 Coated Tablets
CIN 2281715
Distributed By:
Cardinal Health
Dublin Ohio 43017
www.myleader.com
* Please review the disclaimer below.