DULCOLAX PINK- bisacodyl tablet, coated
Boehringer Ingelheim Pharmaceuticals Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Dulcolax® Pink™ tablets
Bisacodyl (USP) 5 mg Tablets/Stimulant Laxative

Drug Facts

Active ingredient (in each tablet)	Purpose
Bisacodyl (USP) 5 mg	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

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.

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 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? 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.

Dulcolax Pink® 25 Tablets Carton

DULCOLAX PINK
bisacodyl tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0597-0169
Route of Administration	ORAL

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

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0597-0169-29	6 in 1 CARTON	06/23/2012	10/29/2021
1		15 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC:0597-0169-26	1 in 1 CARTON	06/23/2012	10/29/2021
2		25 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC:0597-0169-37	2 in 1 CARTON	06/23/2012	10/29/2021
3		15 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part334	06/23/2012	10/29/2021

DULCOLAX PINK
bisacodyl tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0597-0051
Route of Administration	ORAL

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

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0597-0051-86	1 in 1 CARTON	07/01/2014	10/29/2021
1		8 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC:0597-0051-14	1 in 1 CARTON	07/01/2014	10/29/2021
2		38 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC:0597-0051-26	1 in 1 CARTON	07/01/2014	10/29/2021
3		25 in 1 BLISTER PACK; Type 0: Not a Combination Product
4	NDC:0597-0051-29	6 in 1 CARTON	07/01/2014	10/29/2021
4		15 in 1 BLISTER PACK; Type 0: Not a Combination Product
5	NDC:0597-0051-37	2 in 1 CARTON	07/01/2014	10/29/2021
5		15 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part334	07/01/2014	10/29/2021

DULCOLAX PINK
bisacodyl tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0597-0335
Route of Administration	ORAL

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

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0597-0335-34	1 in 1 CARTON	02/25/2016	10/29/2021
1		25 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC:0597-0335-79	6 in 1 CARTON	02/25/2016	10/29/2021
2		15 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC:0597-0335-29	2 in 1 CARTON	02/25/2016	10/29/2021
3		15 in 1 BLISTER PACK; Type 0: Not a Combination Product
4	NDC:0597-0335-02	1 in 1 CARTON	02/25/2016	10/29/2021
4		8 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part334	02/25/2016	10/29/2021

Labeler - Boehringer Ingelheim Pharmaceuticals Inc. (603175944)

Registrant - Boehringer Ingelheim Pharmaceuticals Inc. (603175944)

Revised: 11/2021

Document Id: 3c1d01b4-0164-4ba9-8410-64c5b3b8c850

Set id: 265db5aa-7f7b-b91e-92a3-0aa97b251be5

Version: 4

Effective Time: 20211101

Boehringer Ingelheim Pharmaceuticals Inc.

Dulcolax® Pink™ tablets Bisacodyl (USP) 5 mg Tablets/Stimulant Laxative

Dulcolax® Pink™ tablets
Bisacodyl (USP) 5 mg Tablets/Stimulant Laxative