DRUG FACTS

Drug Details [pdf]

ENTERIC COATED STIMULANT LAXATIVE- bisacodyl tablet, delayed release
Lake Erie Medical DBA Quality Care Products LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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DRUG FACTS

Active ingredient (in each tablet)
Bisacodyl 5 mg

Purpose
Laxative

Uses

relieves occasional constipation
generally produces bowel movement in 6-12 hours

Warnings

Do not use

for longer than one week
when abdominal pain, nausea or vomiting are present
in children under 6 years of age
in persons who cannot swallow without chewing

Ask a doctor before use if you have noticed a sudden change in bowel habits that lasts over two weeks

Ask a doctor or pharmacist before use if you are taking any other drug. Take this product two or more hours before or after other drugs. Laxatives may affect how other drugs work.

When using this product

do not take dose within one hour of taking an antacid or milk
you may experience abdominal discomfort, faintness and cramps

Stop use and ask a doctor if

you have rectal bleeding
you fail to have a bowel movement after use of this product

These may indicate 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 CHEW TABLETS
adults and children 12 years and over: 1-3 tablets once daily
children 6 to 11 years: 1 tablet once daily
children under 6 years: ask a doctor

Other information

store at 20°-25°C (68°-77°F)

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

image description

ENTERIC COATED STIMULANT LAXATIVE
bisacodyl tablet, delayed release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55700-512(NDC: 0536-3381)
Route of Administration	ORAL

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

Ingredient Name	Strength
Inactive Ingredients
ACACIA (UNII: 5C5403N26O)
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)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
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 POTATO (UNII: 5856J3G2A2)
STEARIC ACID (UNII: 4ELV7Z65AP)
SUCROSE (UNII: C151H8M554)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	orange	Score	no score
Shape	ROUND	Size	6mm
Flavor		Imprint Code	TCL;003
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 55700-512-30	30 in 1 BOTTLE; Type 0: Not a Combination Product	03/31/2017	10/11/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part334	09/22/2011	10/11/2019

Labeler - Lake Erie Medical DBA Quality Care Products LLC (831276758)

Name	Address	ID/FEI	Business Operations
Establishment
Lake Erie Medical DBA Quality Care Products LLC		831276758	repack(55700-512)

Revised: 4/2021

Document Id: d4f9d11d-4d55-405c-a000-e453fbca6e40

Set id: d4a631e5-bc14-405e-8820-583ebb3bd384

Version: 4

Effective Time: 20210415

Lake Er

DRUG FACTS

Drug Labeling and Warnings

Drug Details [pdf]

DRUG FACTS