BISACODYL tablet, coated

ACTIVE INGREDIENT

Active ingredeint (in each tablet)

Bisacodyl 5 mg
PURPOSE

Purpose

Stimulant laxative
INDICATIONS & USAGE
Uses
- relieves occasional constipation and irregularity
- this product generally produces a bowel movement in 6 to 12 hours
WARNINGS

Warnings
DO NOT USE
Do not use
- if you cannot swallow without chewing
ASK DOCTOR
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
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
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
PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a health professional before use.
KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

DOSAGE & ADMINISTRATION

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 SAFETY INFORMATION
Other information
- each tablet contains: magnesium 5 mg
- store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F)
- use by expiration date on package
- protect from excessive humidity
INACTIVE INGREDIENT

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? Call 1-877-290-4008
PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BISACODYL
bisacodyl tablet, coated

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

Ingredient Name	Strength
Inactive Ingredients
IRON OXIDES (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SHELLAC (UNII: 46N107B71O)
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)
TALC (UNII: 7SEV7J4R1U)
STEARIC ACID (UNII: 4ELV7Z65AP)
CALCIUM SULFATE ANHYDROUS (UNII: E934B3V59H)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CARNAUBA WAX (UNII: R12CBM0EIZ)
POVIDONE (UNII: FZ989GH94E)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
D&C YELLOW NO. 10 ALUMINUM LAKE (UNII: CQ3XH3DET6)
GELATIN (UNII: 2G86QN327L)
FD&C YELLOW NO. 6 ALUMINUM LAKE (UNII: GYP6Z2JR6Q)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
SUCROSE (UNII: C151H8M554)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYVINYL ACETATE PHTHALATE (UNII: 58QVG85GW3)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
STARCH, CORN (UNII: O8232NY3SJ)
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
ACACIA (UNII: 5C5403N26O)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 41226-003-52	25 in 1 BLISTER PACK; Type 0: Not a Combination Product	06/01/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M007	06/01/2020

Labeler - KROGER COMPANY (006999528)

Registrant - TIME CAP LABORATORIES INC (037052099)

Name	Address	ID/FEI	Business Operations
Establishment
TIME CAP LABS		037052099	manufacture(41226-003)

Bisacodyl by