STIMULANT LAXATIVE ENTERIC COATED- bisacodyl tablet

stimulant laxative enteric coated by

Drug Labeling and Warnings

stimulant laxative enteric coated by is a Otc medication manufactured, distributed, or labeled by Geri-Care Pharmaceutical Corp. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

• 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 rectal bleeding or no bowel movement within 12 hours after using this product. These could be signs of a serious condition.
• if you need a laxative for more than one 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.

Directions

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

Other information

• each tablet contains: magnesium 5 mg
• store at room temperature
• avoid excessive humidity
• Tamper Evident: Do not use if imprinted seal under cap is missing or broken
• package not child resistant

Inactive ingredients

acacia, calcium sulfate, cellulose, corn starch, D&C yellow #10 lake, FD&C yellow #6 lake, gelatin, iron oxide, lactose, magnesium
stearate, PEG, polyvinyl acetate phthalate, povidone, shellac, silica, sodium starch glycolate, stearic acid, sugar, talc, titanium dioxide, wax.

Package Label

HEALTH STAR

THE SENSIBLE CHOICE FOR PRICE AND HEALTH
NDC: 57896-440-01

enteric coated

Bisacodyl

Stimulant laxative
100 Tablets
5 mg each

Compare to the
active ingredient in
Dulcolax® Laxative Tablets*

INGREDIENTS AND APPEARANCE

STIMULANT LAXATIVE ENTERIC COATED 
bisacodyl tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57896-440
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)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
ACACIA (UNII: 5C5403N26O)
CARNAUBA WAX (UNII: R12CBM0EIZ)
STARCH, CORN (UNII: O8232NY3SJ)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
POLYVINYL ACETATE PHTHALATE (UNII: 58QVG85GW3)
POVIDONES (UNII: FZ989GH94E)
SHELLAC (UNII: 46N107B71O)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)
STEARIC ACID (UNII: 4ELV7Z65AP)
SUCROSE (UNII: C151H8M554)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
GELATIN (UNII: 2G86QN327L)

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: 57896-440-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	03/01/2017
2	NDC: 57896-440-10	1000 in 1 BOTTLE; Type 0: Not a Combination Product	03/01/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	03/01/2017

Labeler - Geri-Care Pharmaceutical Corp (611196254)

Registrant - Geri-Care Pharmaceutical Corp (611196254)