DULCOLAX SIMULANT LAXATIVE- bisacodyl tablet, film coated

Dulcolax Simulant Laxative by

Drug Labeling and Warnings

Dulcolax Simulant Laxative by is a Otc medication manufactured, distributed, or labeled by Chattem, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

• adults and children 12 years of age and over: start with 1 tablet/day. If needed, increase to 2 or 3 tablets a day in a single daily dose.
• children 6 to under 12 years of age: 1 tablet per day
• 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

glycerol monostearate, hypromellose, iron oxides, lactose, macrogol 6000, magnesium stearate, methacrylic acid - ethyl acrylate copolymer, polysorbate 80, pregelatinized maize starch, stearic acid, triethyl citrate, water

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

INGREDIENTS AND APPEARANCE

DULCOLAX SIMULANT LAXATIVE 
bisacodyl tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41167-0101
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
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
HYPROMELLOSES (UNII: 3NXW29V3WO)
FERRIC OXIDE RED (UNII: 1K09F3G675)
LACTOSE (UNII: J2B2A4N98G)
POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)
MAGNESIUM STEARATE (UNII: 70097M6I30)
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER (UNII: NX76LV5T8J)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
STARCH, CORN (UNII: O8232NY3SJ)
STEARIC ACID (UNII: 4ELV7Z65AP)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
WATER (UNII: 059QF0KO0R)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41167-0101-0	1 in 1 CARTON	02/12/2021
1		8 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 41167-0101-1	1 in 1 CARTON	02/12/2021
2		10 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC: 41167-0101-2	1 in 1 CARTON	02/12/2021
3		25 in 1 BLISTER PACK; Type 0: Not a Combination Product
4	NDC: 41167-0101-3	2 in 1 CARTON	02/12/2021
4		25 in 1 BLISTER PACK; Type 0: Not a Combination Product
5	NDC: 41167-0101-4	4 in 1 CARTON	02/12/2021
5		25 in 1 BLISTER PACK; Type 0: Not a Combination Product
6	NDC: 41167-0101-5	8 in 1 CARTON	02/12/2021
6		25 in 1 BLISTER PACK; Type 0: Not a Combination Product
7	NDC: 41167-0101-6	3 in 1 CARTON	02/12/2021
7		10 in 1 BLISTER PACK; Type 0: Not a Combination Product
8	NDC: 41167-0101-7	1 in 1 CARTON	06/01/2022
8		6 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 Drug	505G(a)(3)	02/12/2021

Labeler - Chattem, Inc. (003336013)