Drug Facts

Active ingredient (in each tablet)

Bisacodyl 5 mg

Purpose

Stimulant Laxative

Uses

relieves occasional constipation and irregularity
this product generally produces a bowel movement in 6 to 12 hours

Warnings

Do not use

for more than one week unless directed by a doctor
if you cannot swallow without chewing
within 1 hour after taking an antacid or milk

Ask a doctor before use if you have

abdominal pain
nausea
vomiting
a sudden change in bowel habits that lasts longer than 2 weeks

When using this product

abdominal discomfort, faintness, or cramps may occur

Stop use and ask a doctor

if you have no bowel movement within 12 hours
if you have rectal bleeding
these could be signs of a serious condition

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

do not take more than directed
swallow whole, do not chew or crush
take recommended dose in a single daily dose
take with water
adults and children 12 years and older: take 1-3 (usually 2) tablets daily
chidren 12 and under: ask a doctor

Other information

store at room temperature
avoid excessive humidity

Inactive ingredients:

acacia, ammonium hydroxide, calcium carbonate, corn starch, D&C yellow #10 lake, FD&C yellow #6 lake, hypromellose, iron oxide black, lactose, magnesium stearate, methylparaben, PEG, polydextrose, polyvinyl acetate phthalate, propylparaben, propylene glycol, povidone, shellac, simethicone, silica, sodium alginate, sodium benzoate, sodium bicarbonate, stearic acid, sucrose, talc, titanium dioxide, triacetin, triethyl citrate, wax.

Questions or Comments?

732-430-2208

www.satiusrx.com

Package Labeling:

Package label

BET-R-PREP BISACODYL
bisacodyl tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71890-330
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
SHELLAC (UNII: 46N107B71O)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
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)
ACACIA (UNII: 5C5403N26O)
AMMONIA (UNII: 5138Q19F1X)
CALCIUM CARBONATE (UNII: H0G9379FGK)
STARCH, CORN (UNII: O8232NY3SJ)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)
MAGNESIUM STEARATE (UNII: 70097M6I30)
METHYLPARABEN (UNII: A2I8C7HI9T)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POLYDEXTROSE (UNII: VH2XOU12IE)
POLYVINYL ACETATE PHTHALATE (UNII: 58QVG85GW3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POVIDONE (UNII: FZ989GH94E)

Product Characteristics
Color	orange	Score	no score
Shape	ROUND	Size	1mm
Flavor		Imprint Code	5
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:71890-330-25	1 in 1 BOX	11/18/2017
1		25 in 1 PACKAGE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part334	11/18/2017

Labeler - Satius Pharmaceuticals, LLC (080518631)

BET-R-PREP Bisacodyl