BET-R-PREP BISACODYL- bisacodyl tablet

BET-R-PREP Bisacodyl by

Drug Labeling and Warnings

BET-R-PREP Bisacodyl by is a Otc medication manufactured, distributed, or labeled by Satius Pharmaceuticals, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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?

contact us at:

732-430-2208

www.satiusrx.com

Package Labeling:

INGREDIENTS AND APPEARANCE

BET-R-PREP BISACODYL 
bisacodyl tablet

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

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

Inactive Ingredients
Ingredient Name	Strength
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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71890-330-25	1 in 1 BOX	11/18/2017
1		25 in 1 PACKAGE; 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	11/18/2017

Labeler - Satius Pharmaceuticals, LLC (080518631)