Physicians Total Care, Inc.
Dulcolax ® Tablets
FULL PRESCRIBING INFORMATION: CONTENTS*
FULL PRESCRIBING INFORMATION
Drug Facts
Active ingredient (in each tablet)
|
Purpose
|
Bisacodyl USP 5 mg .................................... |
Stimulant laxative |
Dulcolax Uses
Purpose
- for temporary relief of occasional constipation and irregularity
- this product generally produces bowel movement in 6 to 12 hours
Warnings
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 and 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 of age and over |
1 to 3 tablets in a single daily dose |
children 6 to under 12 years of age |
1 tablet in a single daily dose |
children under 2 years of age |
ask a doctor |
Dulcolax Other information
- store at 20-25°C (68-77°F
- protect from excessive humidity
Inactive ingredients
acacia, acetylated monoglyceride, carnauba wax, cellulose acetate phthalate, corn starch, dibutyl phthalate, docusate sodium, gelatin, glycerin, iron oxides, kaolin, lactose, magnesium stearate, methylparaben, pharmaceutical glaze, polyethylene glycol, povidone, propylparaben, Red No. 30 lake, sodium benzoate, sorbitan monooleate, sucrose, talc, titanium dioxide, white wax, Yellow No. 10 lake
Dulcolax
bisacodyl TABLET, COATED
Product Information
|
Product Type
|
Human otc drug label |
Item Code (Source)
|
NDC:54868-0016(NDC:0597-0012) |
Route of Administration
|
ORAL |
DEA Schedule
|
|
Active Ingredient/Active Moiety
|
Ingredient Name
|
Basis of Strength
|
Strength
|
Bisacodyl Bisacodyl |
|
5 mg
|
Product Characteristics
|
Color
|
Size
|
Imprint Code
|
Shape
|
ORANGE |
5 mm |
12; |
ROUND |
Packaging
|
#
|
Item Code
|
Package Description
|
Marketing Start Date
|
Marketing End Date
|
1 |
|
10 in 1 BLISTER PACK |
|
|
2 |
NDC:54868-0016-0 |
1 in 1 CARTON |
|
|
Marketing Information
|
Marketing Category
|
Application Number or Monograph Citation
|
Marketing Start Date
|
Marketing End Date
|
part |
part334 |
2010-05-19 |
|
|