Bisacodyl Tablets, USP

Drug Labeling and Warnings

Drug Details [pdf]

BISACODYL- 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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Bisacodyl Tablets, USP

Active ingredient (in each tablet)

Bisacodyl 5 mg

Purpose

Stimulant laxative

Uses

• for temporary relief of occasional constipation and irregularity
• this product generally produces 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.

Directions

take with a glass of water

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

Other information

• store at 20°-25°C (68°-77°F)
• protect from excessive humidity

You may report serious side effects to: 130 Vintage Drive, Huntsville, AL 35811.

Inactive ingredients

calcium sulfate, carnauba wax, colloidal silicon dioxide, croscarmellose sodium, D&C yellow #10, edible ink, FD&C yellow #6, gelatin, hypromellose, kaolin, lactose, magnesium stearate, methacrylic acid copolymer, microcrystalline cellulose, mineral oil, polyethylene glycol, propylene glycol, stearic acid, sucrose, sugar, talc, titanium dioxide, triethyl citrate

Mfg. for:
Qualitest Pharmaceuticals
Huntsville, AL 35811

REV. 01/10

BISACODYL 
bisacodyl tablet, delayed release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55700-502(NDC: 0603-2483)
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 (UNII: WAT0DDB505)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CARNAUBA WAX (UNII: R12CBM0EIZ)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GELATIN (UNII: 2G86QN327L)
HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4)
KAOLIN (UNII: 24H4NWX5CO)
LACTOSE (UNII: J2B2A4N98G)
MAGNESIUM STEARATE (UNII: 70097M6I30)
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
MINERAL OIL (UNII: T5L8T28FGP)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
STEARIC ACID (UNII: 4ELV7Z65AP)
SUCROSE (UNII: C151H8M554)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)

Product Characteristics
Color	ORANGE	Score	no score
Shape	ROUND	Size	6mm
Flavor		Imprint Code	S1
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55700-502-30	30 in 1 BOTTLE; Type 0: Not a Combination Product	02/10/2017	10/11/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part334	02/10/2017	10/11/2019

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

Establishment
Name	Address	ID/FEI	Business Operations
Lake Erie Medical DBA Quality Care Products LLC		831276758	repack(55700-502)

Revised: 10/2019

Document Id: d00ca414-1475-4896-9315-2eb95b176f23

34390-5

Set id: dc6c2ec0-d811-4951-90c4-800fe127f3b7

Version: 3

Effective Time: 20191015

 

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