FDA Label for Bisacodyl
View Indications, Usage & Precautions
- ACTIVE INGREDIENT (IN EACH TABLET)
- PURPOSE
- USES
- 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,
- KEEP OUT OF REACH OF CHILDREN.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Bisacodyl Product Label
The following document was submitted to the FDA by the labeler of this product Remedyrepack 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.
Active Ingredient (In Each Tablet)
Bisacodyl USP, 5 mg
Purpose
Stimulant laxative
Uses
- 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)
- do not use within 1 hour after taking an antacid or milk
- you may have stomach discomfort, faintness and 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
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 (1-800-222-1222) 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 | take 1 tablet in a single
daily dose |
| children under 6 years | ask a doctor |
Other Information
- TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
- store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
- avoid excessive humidity
- see end flap for expiration date and lot number
Inactive Ingredients
acacia, ammonium hydroxide, calcium carbonate, carnauba wax, colloidal anhydrous silica, corn starch, D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake,
hypromellose, iron oxide black, lactose anhydrous, magnesium stearate, methylparaben, polydextrose, polyethylene glycol, polyvinyl acetate phthalate, povidone, propylene glycol, propylparaben, shellac
glaze, simethicone, sodium alginate, sodium benzoate, sodium bicarbonate, stearic acid, sucrose, talc, titanium dioxide, triacetin, triethyl citrate
Questions Or Comments?
(800)-616-2471
Package Label.Principal Display Panel
DRUG: Bisacodyl
GENERIC: Bisacodyl
DOSAGE: TABLET, COATED
ADMINSTRATION: ORAL
NDC: 70518-1864-0
COLOR: orange
SHAPE: ROUND
SCORE: No score
SIZE: 6 mm
IMPRINT: 5
PACKAGING: 30 in 1 BLISTER PACK
ACTIVE INGREDIENT(S):
- BISACODYL 5mg in 1
- ACACIA
- DIMETHICONE
- WATER
- SHELLAC
- PROPYLENE GLYCOL
- PROPYLPARABEN
- SODIUM ALGINATE
- POVIDONE
- SODIUM BENZOATE
- TITANIUM DIOXIDE
- TRIACETIN
- SODIUM BICARBONATE
- STEARIC ACID
- SUCROSE
- TALC
- D&C YELLOW NO. 10
- FD&C YELLOW NO. 6
- STARCH, CORN
- HYPROMELLOSE, UNSPECIFIED
- CALCIUM CARBONATE
- CARNAUBA WAX
- SILICON DIOXIDE
- Polyvinyl Acetate Phthalate
- FERROSOFERRIC OXIDE
- POLYDEXTROSE
- POLYETHYLENE GLYCOL, UNSPECIFIED
- METHYLPARABEN
- ANHYDROUS LACTOSE
- MAGNESIUM STEARATE
- TRIETHYL CITRATE
INACTIVE INGREDIENT(S):
* Please review the disclaimer below.