DULCOLAX PINK- bisacodyl tablet, coated

Dulcolax Pink by

Drug Labeling and Warnings

Dulcolax Pink 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

PURPOSE

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

INDICATIONS & USAGE

ASK DOCTOR

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

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

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

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

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 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 Red #27 aluminum lake, ethanol, FD&C Blue #2 aluminum lake, FD&C Yellow #6 aluminum lake, glycerol, glyceryl monostearate, iron oxide, lactose monohydrate, magnesium stearate, methacrylic acid ethyl acrylate copolymer,methyl paraben, modified corn starch, polyethylene glycol 6000, polysorbate 80, povidone, propylene glycol, 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 Pink® 25 Tablets Carton

PRINCIPAL DISPLAY PANEL

Dulcolax Pink® 25 Tablets Carton

PRINCIPAL DISPLAY PANEL

Dulcolax Pink® 25 Tablets Carton

INGREDIENTS AND APPEARANCE

DULCOLAX PINK 
bisacodyl tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0597-0169
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)
STARCH, CORN (UNII: O8232NY3SJ)
D&C RED NO. 27 (UNII: 2LRS185U6K)
ALCOHOL (UNII: 3K9958V90M)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
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)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
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	PINK	Score	no score
Shape	ROUND	Size	6mm
Flavor		Imprint Code	DW
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0597-0169-29	6 in 1 CARTON	06/23/2012
1		15 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 0597-0169-26	1 in 1 CARTON	06/23/2012
2		25 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC: 0597-0169-37	2 in 1 CARTON	06/23/2012
3		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	06/23/2012

DULCOLAX PINK 
bisacodyl tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0597-0051
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)
STARCH, CORN (UNII: O8232NY3SJ)
D&C RED NO. 27 (UNII: 2LRS185U6K)
ALCOHOL (UNII: 3K9958V90M)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
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)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
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	PINK	Score	no score
Shape	ROUND	Size	6mm
Flavor		Imprint Code	DW
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0597-0051-86	1 in 1 CARTON	07/01/2014
1		8 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 0597-0051-14	1 in 1 CARTON	07/01/2014
2		38 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC: 0597-0051-26	1 in 1 CARTON	07/01/2014
3		25 in 1 BLISTER PACK; Type 0: Not a Combination Product
4	NDC: 0597-0051-29	6 in 1 CARTON	07/01/2014
4		15 in 1 BLISTER PACK; Type 0: Not a Combination Product
5	NDC: 0597-0051-37	2 in 1 CARTON	07/01/2014
5		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	07/01/2014

DULCOLAX PINK 
bisacodyl tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0597-0335
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)
STARCH, CORN (UNII: O8232NY3SJ)
D&C RED NO. 27 (UNII: 2LRS185U6K)
ALCOHOL (UNII: 3K9958V90M)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
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)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
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	PINK	Score	no score
Shape	ROUND	Size	6mm
Flavor		Imprint Code	DW
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0597-0335-34	1 in 1 CARTON	02/25/2016
1		25 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 0597-0335-79	6 in 1 CARTON	02/25/2016
2		15 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC: 0597-0335-29	2 in 1 CARTON	02/25/2016
3		15 in 1 BLISTER PACK; Type 0: Not a Combination Product
4	NDC: 0597-0335-02	1 in 1 CARTON	02/25/2016
4		8 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	02/25/2016

Labeler - Boehringer Ingelheim Pharmaceuticals Inc. (603175944)

Registrant - Boehringer Ingelheim Pharmaceuticals Inc. (603175944)