STIMULANT LAXATIVE- bisacodyl tablet, delayed release

STIMULANT LAXATIVE by

Drug Labeling and Warnings

STIMULANT LAXATIVE by is a Otc medication manufactured, distributed, or labeled by RETAIL BUSINESS SERVICES, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient                 

(In each tablet)

  Bisacodyl 5mg

Purpose

Stimulant Laxative

INDICATIONS & USAGE

Uses

• relieves occasional constipation and irregularity
• this product generally produces a 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

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 1(800) 222-1222.

DOSAGE & ADMINISTRATION

• take with a glass of water
• adults and children 12 years and over: take 1 to 3 tablets in a single daily dose
• children 6 to under 12 years: take 1 tablet in a single daily dose
• children under 6 years: ask a doctor

Inactive ingredients

Acadia, 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 Phthalates, Povidone, Shellac, Sodium Starch Glycolate, Stearic Acid, Sugar, Talc, Titanium Dioxide

Questions or comments?

1-888-333-9792

DISPLAY PANEL

GENTLE LAXATIVE

BISACODYL 5 mg

GENTLE YET EFFECTIVE STIMULANT LAXATIVE

25 TABLETS

ENTERIC COATED

INGREDIENTS AND APPEARANCE

STIMULANT LAXATIVE 
bisacodyl tablet, delayed release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72476-845
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
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)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
ACACIA (UNII: 5C5403N26O)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
POLYVINYL ACETATE PHTHALATE (UNII: 58QVG85GW3)
POVIDONE (UNII: FZ989GH94E)
SHELLAC (UNII: 46N107B71O)
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)
STEARIC ACID (UNII: 4ELV7Z65AP)
SUCROSE (UNII: C151H8M554)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

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: 72476-845-25	1 in 1 PACKAGE	03/30/2021
1		25 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	M007	03/30/2021

Labeler - RETAIL BUSINESS SERVICES, LLC (967989935)