Bisacodyl by Spirit Pharmaceuticals LLC BISACODYL tablet

Bisacodyl by

Drug Labeling and Warnings

Bisacodyl by is a Otc medication manufactured, distributed, or labeled by Spirit Pharmaceuticals LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient (in each tablet)

Bisacodyl (USP) 5 mg

Purpose

Stimulant laxative

Uses

• 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

■ do not chew or crush tablet(s)
■ it may cause stomach discomfort, faintness and cramps
■ 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

PREGNANCY OR BREAST FEEDING

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

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

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

OTHER SAFETY INFORMATION

Other information
■ each tablet contains: magnesium 5 mg
■ store at 20-25°C (68-77°F)
■ protect from excessive humidity

Inactive ingredients

Acacia, anhydrous calcium sulfate, anhydrous lactose,
carnauba wax, colloidal silicon dioxide, corn starch, D&C
Yellow #10 Aluminum Lake, FD&C Yellow #6 Aluminum
Lake, gelatin, iron oxide, iron oxide black, iron oxide yellow
(iron oxide ochre), magnesium stearate, microcrystalline
cellulose, polyethylene glycol (PEG) 400, polyvinyl acetate
phthalate, povidone, shellac, sodium starch glycolate, stearic
acid, sugar, talc, titanium dioxide

QUESTIONS

Questions or comments? 1-888-333-9792

PRINCIPAL DISPLAY PANEL

Compare to the active ingredient
in Dulcolax®†

GENTLE
LAXATIVE

Bisacodyl Tablets,
USP 5 mg

gentle
overnight relief

†This product is not manufactured or distributed by

Boehringer Ingelheim Pharmaceuticals, Inc., owner of the
registered trademark Dulcolax®

INGREDIENTS AND APPEARANCE

BISACODYL 
bisacodyl tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68210-3120
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)
CALCIUM SULFATE ANHYDROUS (UNII: E934B3V59H)
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
CARNAUBA WAX (UNII: R12CBM0EIZ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STARCH, CORN (UNII: O8232NY3SJ)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GELATIN (UNII: 2G86QN327L)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
POLYVINYL ACETATE PHTHALATE (UNII: 58QVG85GW3)
POVIDONE K30 (UNII: U725QWY32X)
SHELLAC (UNII: 46N107B71O)
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)
STEARIC ACID (UNII: 4ELV7Z65AP)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SUCROSE (UNII: C151H8M554)

Product Characteristics
Color	orange	Score	no score
Shape	ROUND	Size	5mm
Flavor		Imprint Code	TCL003
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68210-3120-2	1 in 1 CARTON	03/11/2020
1		25 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 68210-3120-1	1 in 1 CARTON	03/11/2020
2		200 in 1 BOTTLE; 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	03/11/2020

Labeler - Spirit Pharmaceuticals LLC (179621011)

Establishment
Name	Address	ID/FEI	Business Operations
Time Cap Laboratories, Inc.		037052099	manufacture(68210-3120)