DULCOLAX SIMULANT LAXATIVE- bisacodyl tablet, film coated 
Chattem, Inc.

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Dulcolax Stimulant Laxative CMP-CHA

Dulcolax®

Stimulant Laxative Tablets

Drug Facts

Active ingredient (in each tablet)

Bisacodyl (USP) 5 mg

Purpose

Stimulant laxative

Use

● for 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

● noticed 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 fail to have a 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 6 years of age                               ask a doctor

Other information

● do not use if individual blister unit is open or torn

● store at 20°-25°C (68°-77°F)

● protect from excessive humidity

Inactive ingredients

acacia gum, ammonium hydroxide, beeswax, carnauba wax, corn starch, D&C red #30 aluminum lake, D&C yellow #10 aluminum lake, glycerin, glyceryl monostearate, iron oxides, lactose monohydrate, magnesium stearate, methacrylic acid ethyl acrylate copolymer, methylparaben, modified starch, polyethylene glycol 6000, polysorbate 80, povidone, propylene glycol, propylparaben, shellac, sodium benzoate, sucrose, talc, titanium dioxide, triethyl citrate

Questions?

Call 1-866-844-2798 or visit www.Dulcolax.com

Keep carton as it contains important product information.

PRINCIPAL DISPLAY PANEL

OVERNIGHT RELIEF
Dulcolax
LAXATIVE
25 comfort coated Tablets

PRINCIPAL DISPLAY PANEL
OVERNIGHT RELIEF
Dulcolax
LAXATIVE
25 comfort coated Tablets

DULCOLAX SIMULANT LAXATIVE 
bisacodyl tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41167-0101
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BISACODYL (UNII: 10X0709Y6I) (DEACETYLBISACODYL - UNII:R09078E41Y) BISACODYL5 mg
Inactive Ingredients
Ingredient NameStrength
ACACIA (UNII: 5C5403N26O)  
AMMONIA (UNII: 5138Q19F1X)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
STARCH, CORN (UNII: O8232NY3SJ)  
D&C RED NO. 30 (UNII: 2S42T2808B)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
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)  
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER (UNII: NX76LV5T8J)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
Product Characteristics
ColororangeScoreno score
ShapeROUNDSize5mm
FlavorImprint Code 12
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41167-0101-01 in 1 CARTON02/12/2021
18 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:41167-0101-11 in 1 CARTON02/12/2021
210 in 1 BLISTER PACK; Type 0: Not a Combination Product
3NDC:41167-0101-21 in 1 CARTON02/12/2021
325 in 1 BLISTER PACK; Type 0: Not a Combination Product
4NDC:41167-0101-32 in 1 CARTON02/12/2021
425 in 1 BLISTER PACK; Type 0: Not a Combination Product
5NDC:41167-0101-44 in 1 CARTON02/12/2021
525 in 1 BLISTER PACK; Type 0: Not a Combination Product
6NDC:41167-0101-58 in 1 CARTON02/12/2021
625 in 1 BLISTER PACK; Type 0: Not a Combination Product
7NDC:41167-0101-63 in 1 CARTON02/12/2021
710 in 1 BLISTER PACK; Type 0: Not a Combination Product
8NDC:41167-0101-71 in 1 CARTON06/01/2022
86 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph Drug505G(a)(3)02/12/2021
Labeler - Chattem, Inc. (003336013)

Revised: 11/2023
Document Id: 8d9b9eeb-bd27-4cd7-b27b-656c560c63d4
Set id: d285651b-7ccc-4ae5-a862-7a38dffefa28
Version: 7
Effective Time: 20231103
 
Chattem, Inc.