DULCOLAX- bisacodyl tablet, coated

Dulcolax by

Drug Labeling and Warnings

Dulcolax by is a Otc medication manufactured, distributed, or labeled by Mechanical Servants, Inc., Boehringer Ingelheim Promeco S.A. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each tablet)

Bisacodyl USP 5 mg

Purpose

Stimulant laxative

Use

• 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)
• do not use within 1 hour after taking an antacid or milk
• it may cause stomach discomfort, faintness and cramps

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: 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 6 years of age: ask a doctor

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

Questions

1-888-285-9159 (English/Spanish)

Or visit www.DULCOLAX.com

SPL UNCLASSIFIED SECTION

Repackaged and distributed by Convenience Valet® Melrose Park, IL 60160

PRINCIPAL DISPLAY PANEL - 5 mg Pouch Package

CONVENIENCE
CV
VALET®

DRINKING CUP
INCLUDED

Dulcolax®
LAXATIVE
(bisacodyl USP 5 mg)
C6A

3 TABLETS

INGREDIENTS AND APPEARANCE

DULCOLAX 
bisacodyl tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 29485-6741(NDC:0597-0012)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
bisacodyl (UNII: 10X0709Y6I) (bisacodyl - UNII:10X0709Y6I)	bisacodyl	5 mg

Inactive Ingredients
Ingredient Name	Strength
acacia (UNII: 5C5403N26O)
carnauba wax (UNII: R12CBM0EIZ)
cellacefate (UNII: F2O5O2OI9F)
starch, corn (UNII: O8232NY3SJ)
dibutyl phthalate (UNII: 2286E5R2KE)
docusate sodium (UNII: F05Q2T2JA0)
gelatin (UNII: 2G86QN327L)
glycerin (UNII: PDC6A3C0OX)
kaolin (UNII: 24H4NWX5CO)
lactose (UNII: J2B2A4N98G)
magnesium stearate (UNII: 70097M6I30)
methylparaben (UNII: A2I8C7HI9T)
shellac (UNII: 46N107B71O)
polyethylene glycols (UNII: 3WJQ0SDW1A)
povidone (UNII: FZ989GH94E)
propylparaben (UNII: Z8IX2SC1OH)
sodium benzoate (UNII: OJ245FE5EU)
sorbitan monooleate (UNII: 06XEA2VD56)
sucrose (UNII: C151H8M554)
talc (UNII: 7SEV7J4R1U)
titanium dioxide (UNII: 15FIX9V2JP)
white wax (UNII: 7G1J5DA97F)
diacetylated monoglycerides (UNII: 5Z17386USF)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Product Characteristics
Color	ORANGE	Score	no score
Shape	ROUND	Size	5mm
Flavor		Imprint Code	12;BI
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 29485-6741-3	1 in 1 PACKAGE
1		3 in 1 POUCH

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part334	01/01/2010

Labeler - Mechanical Servants, Inc. (005530951)

Establishment
Name	Address	ID/FEI	Business Operations
Boehringer Ingelheim Promeco S.A. de C.V.		812579472	MANUFACTURE

Establishment
Name	Address	ID/FEI	Business Operations
Mechanical Servants, Inc.		005530951	RELABEL