FDA Label for Gentle Laxative Bisacodyl
View Indications, Usage & Precautions
- DRUG FACTS : ACTIVE INGREDIENT
- DRUG FACTS
- USES
- WARNINGS
- DO NOT USE
- ASK A DOCTOR BEFORE USE
- WHEN USING THIS PRODUCT
- STOP USE AND ASK A DOCTOR IF
- IF PREGNANT OR BREAST-FEEDING,
- KEEP OUT OF REACH OF CHILDREN.
- DOSAGE & ADMINISTRATION
- OTHER INFORMATION
- INACTIVE INGREDIENT
- QUESTIONS?
- TAMPER EVIDENT SEAL:
- INTENDED USE OF THE DEVICE
- PACKAGE LABEL
Gentle Laxative Bisacodyl Product Label
The following document was submitted to the FDA by the labeler of this product Neilmed Pharmaceuticals Inc. 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.
Drug Facts : Active Ingredient
(in each suppository)
Bisacodyl 10 mg
Drug Facts
Purpose
Bisacodyl 10 mg ................................. Stimulant Laxative
Uses
■ for relief of occasional constipation
■ this product generally produces bowel movement in 15 to 60 minutes
Warnings
■ For rectal use only
Do Not Use
■ when abdominal pain, nausea or vomiting are present
■ for a period longer than 1 week
Ask A Doctor Before Use
if you have noticed a sudden change in bowel habits that lasts over a period of 2 weeks
When Using This Product
it may cause abdominal discomfort, faintness, rectal bleeding and mild cramps
Stop Use And Ask A Doctor If
■ you have rectal bleeding
■ you fail to have a bowel movement after using this product. This may indicate a serious condition
If Pregnant Or Breast-Feeding,
ask a health professional before use.
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center right away.
Dosage & Administration
Directions
■ detach one suppository from the strip
■ remove wrapper before inserting into the rectum
adults and children 12 and over : 1 suppository once daily
children 6 to under 12 years : ½ suppository once daily
children under 6 years : do not use
Other Information
■ Store at room temperature. Do not exceed 30° C (86° F)
■ Lot No. & Exp. Date: see wrapper or box
Inactive Ingredient
hydrogenated vegetable oil
Questions?
Adverse Drug Event Call: 1(877) 477-8633
Tamper Evident Seal:
Do not use if wrapper on an individual suppository is broken or missing.
Intended Use Of The Device
Prompt, predictable relief from constipation
* Please review the disclaimer below.