DULCOLAX- bisacodyl tablet, coated

Dulcolax by

Drug Labeling and Warnings

Dulcolax by is a Otc medication manufactured, distributed, or labeled by Boehringer Ingelheim Pharmaceuticals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Drug Facts

• Active ingredient (in each tablet): Purpose
• Bisacodyl (USP) 5 mg: Stimulant laxative

INDICATIONS & USAGE

Use

• for temporary relief of occasional constipation and irregularity
• this product generally produces bowel movement in 6 to 12 hours

WARNINGS

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

• it may cause stomach discomfort, faintness and cramps
• do not chew or crush tablet(s)
• 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.

DOSAGE & ADMINISTRATION

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 6 years of age: ask a doctor

STORAGE AND HANDLING

Other information

• store at 20-25°C (68-77°F
• protect from excessive humidity

INACTIVE INGREDIENT

Inactive ingredients acacia gum, ammonium hydroxide, beeswax, carnauba wax, D&C Yellow #10 aluminum lake, D&C Red #30 aluminum lake, glycerin, glyceryl monostearate, iron oxide, lactose monohydrate, magnesium stearate, methacrylic acid ethyl acrylate copolymer, methyl paraben, modified corn starch, polyethylene glycol 6000, polysorbate 80, povidone, propyl paraben, shellac, sodium benzoate, sucrose, talc, titanium dioxide, triethyl citrate

QUESTIONS

Questions? call 1-888-285-9159 (English/Spanish), M – F, 8:30 – 5 EST, or visit www.Dulcolax.com

Distributed by: Boehringer Ingelheim (BI) Consumer Health Care Products Division of BI Pharmaceuticals, Inc., Ridgefield, CT 06877. Product of Italy. Manufactured in Mexico. © 2016, BI Pharmaceuticals, Inc. All rights reserved.

PRINCIPAL DISPLAY PANEL

Dulcolax® 25 Tablets Carton

PRINCIPAL DISPLAY PANEL

Dulcolax® 8 Tablets Carton

INGREDIENTS AND APPEARANCE

DULCOLAX 
bisacodyl tablet, coated

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BISACODYL (UNII: 10X0709Y6I) (DEACETYLBISACODYL - UNII:R09078E41Y)	BISACODYL	5 mg

Inactive Ingredients
Ingredient Name	Strength
ACACIA (UNII: 5C5403N26O)
AMMONIA (UNII: 5138Q19F1X)
YELLOW WAX (UNII: 2ZA36H0S2V)
CARNAUBA WAX (UNII: R12CBM0EIZ)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
D&C RED NO. 30 (UNII: 2S42T2808B)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
FERRIC OXIDE RED (UNII: 1K09F3G675)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)
METHYLPARABEN (UNII: A2I8C7HI9T)
POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
SHELLAC (UNII: 46N107B71O)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SUCROSE (UNII: C151H8M554)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
STARCH, CORN (UNII: O8232NY3SJ)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0597-0012-26	1 in 1 CARTON	10/01/2001
1		25 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 0597-0012-11	1 in 1 CARTON	10/01/2001
2		10 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC: 0597-0012-58	6 in 1 CARTON	10/01/2001
3		25 in 1 BLISTER PACK; Type 0: Not a Combination Product
4	NDC: 0597-0012-59	8 in 1 CARTON	10/01/2001
4		25 in 1 BLISTER PACK; Type 0: Not a Combination Product
5	NDC: 0597-0012-50	2 in 1 CARTON	10/01/2001
5		25 in 1 BLISTER PACK; Type 0: Not a Combination Product
6	NDC: 0597-0012-38	1 in 1 CARTON	10/01/2001
6		8 in 1 BLISTER PACK; Type 0: Not a Combination Product
7	NDC: 0597-0012-00	4 in 1 CARTON	10/01/2001
7		25 in 1 BLISTER PACK; Type 0: Not a Combination Product
8	NDC: 0597-0012-37	2 in 1 CARTON	10/01/2001
8		15 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	10/01/2001

DULCOLAX 
bisacodyl tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0597-0340
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BISACODYL (UNII: 10X0709Y6I) (DEACETYLBISACODYL - UNII:R09078E41Y)	BISACODYL	5 mg

Inactive Ingredients
Ingredient Name	Strength
ACACIA (UNII: 5C5403N26O)
AMMONIA (UNII: 5138Q19F1X)
YELLOW WAX (UNII: 2ZA36H0S2V)
CARNAUBA WAX (UNII: R12CBM0EIZ)
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE) (UNII: 461P5CJN6T)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
D&C RED NO. 30 (UNII: 2S42T2808B)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
FERRIC OXIDE RED (UNII: 1K09F3G675)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)
METHYLPARABEN (UNII: A2I8C7HI9T)
POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
SHELLAC (UNII: 46N107B71O)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SUCROSE (UNII: C151H8M554)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0597-0340-48	1 in 1 CARTON	08/01/2013
1		25 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 0597-0340-71	1 in 1 CARTON	08/01/2013
2		10 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC: 0597-0340-64	6 in 1 CARTON	08/01/2013
3		25 in 1 BLISTER PACK; Type 0: Not a Combination Product
4	NDC: 0597-0340-97	8 in 1 CARTON	08/01/2013
4		25 in 1 BLISTER PACK; Type 0: Not a Combination Product
5	NDC: 0597-0340-54	2 in 1 CARTON	08/01/2013
5		25 in 1 BLISTER PACK; Type 0: Not a Combination Product
6	NDC: 0597-0340-82	1 in 1 CARTON	08/01/2013
6		8 in 1 BLISTER PACK; Type 0: Not a Combination Product
7	NDC: 0597-0340-70	4 in 1 CARTON	08/01/2013
7		25 in 1 BLISTER PACK; Type 0: Not a Combination Product
8	NDC: 0597-0340-72	2 in 1 CARTON	08/01/2013
8		15 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	08/01/2013

Labeler - Boehringer Ingelheim Pharmaceuticals, Inc. (603175944)

Registrant - Boehringer Ingelheim Pharmaceuticals, Inc. (603175944)