DULCOLAX STIMULANT LAXATIVE- bisacodyl tablet, coated 
Chattem, 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 Stimulant Laxative

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

● contains FD&C Yellow No. 6

● 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 senegal gum, ammonium hydroxide, calcium carbonate, carnauba wax, colloidal anhydrous silica, corn starch, D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, iron oxides, lactose, magnesium stearate, methylparaben, polydextrose, polyethylene glycol, polyvinyl acetate phthalate, povidone, propylene glycol, propylparaben, shellac, simethicone, sodium alginate, sodium benzoate, sodium bicarbonate, stearic acid, sucrose, talc, titanium dioxide, triacetin, triethyl citrate

Questions?

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

Keep carton as it contains important product information.

PRINCIPAL DISPLAY PANEL

Dulcolax
LAXATIVE
50 TABLETS

PRINICPAL DISPLAY PANEL
Dulcolax
LAXATIVE
50 TABLETS

DULCOLAX STIMULANT LAXATIVE 
bisacodyl tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41167-0200
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)  
CALCIUM CARBONATE (UNII: H0G9379FGK)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
STARCH, CORN (UNII: O8232NY3SJ)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
POLYDEXTROSE (UNII: VH2XOU12IE)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
Polyvinyl Acetate Phthalate (UNII: 58QVG85GW3)  
POVIDONE (UNII: FZ989GH94E)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
SHELLAC (UNII: 46N107B71O)  
SODIUM ALGINATE (UNII: C269C4G2ZQ)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
SUCROSE (UNII: C151H8M554)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIACETIN (UNII: XHX3C3X673)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
Product Characteristics
ColorORANGEScoreno score
ShapeROUNDSize5mm
FlavorImprint Code DU
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41167-0200-51 in 1 CARTON02/25/2019
18 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:41167-0200-68 in 1 CARTON04/11/2019
225 in 1 BLISTER PACK; Type 0: Not a Combination Product
3NDC:41167-0200-83 in 1 CARTON01/02/2019
310 in 1 BLISTER PACK; Type 0: Not a Combination Product
4NDC:41167-0200-32 in 1 CARTON01/02/2019
425 in 1 BLISTER PACK; Type 0: Not a Combination Product
5NDC:41167-0200-21 in 1 CARTON02/15/2019
525 in 1 BLISTER PACK; Type 0: Not a Combination Product
6NDC:41167-0200-11 in 1 CARTON03/01/2019
610 in 1 BLISTER PACK; Type 0: Not a Combination Product
7NDC:41167-0200-44 in 1 CARTON01/02/2019
725 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart33401/02/2019
Labeler - Chattem, Inc. (003336013)

Revised: 1/2019
Document Id: b68003b7-c908-431e-9165-830bbe154056
Set id: e0dcae0f-6dca-4700-a415-de2274e6f779
Version: 2
Effective Time: 20190102
 
Chattem, Inc.