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Bisacodyl by Lake Erie Medical DBA Quality Care Products LLC

Dosage form: tablet, delayed release
Ingredients: BISACODYL 5mg
Labeler: Lake Erie Medical DBA Quality Care Products LLC
NDC Code: 55700-502

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.

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 over1 to 3 tablets in a single daily dose
children 6 to under 12 years1 tablet in a single daily dose
children under 6 yearsask 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 TypeHUMAN OTC DRUGItem Code (Source)NDC:55700-502(NDC:0603-2483)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BISACODYL (DEACETYLBISACODYL) BISACODYL5 mg
Inactive Ingredients
Ingredient NameStrength
CALCIUM SULFATE 
SILICON DIOXIDE 
CARNAUBA WAX 
CROSCARMELLOSE SODIUM 
D&C YELLOW NO. 10 
FD&C YELLOW NO. 6 
GELATIN 
HYPROMELLOSE 2910 (5 MPA.S) 
KAOLIN 
LACTOSE 
MAGNESIUM STEARATE 
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A 
CELLULOSE, MICROCRYSTALLINE 
MINERAL OIL 
POLYETHYLENE GLYCOLS 
PROPYLENE GLYCOL 
STEARIC ACID 
SUCROSE 
TALC 
TITANIUM DIOXIDE 
TRIETHYL CITRATE 
Product Characteristics
ColorORANGEScoreno score
ShapeROUNDSize6mm
FlavorImprint CodeS1
Contains    
Packaging
#Item CodePackage Description
1NDC:55700-502-3030 TABLET, DELAYED RELEASE in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart33402/10/2017
Labeler - Lake Erie Medical DBA Quality Care Products LLC (831276758)
Establishment
NameAddressID/FEIOperations
Lake Erie Medical DBA Quality Care Products LLC831276758repack(55700-502)

Revised: 08/2017
 
Lake Erie Medical DBA Quality Care Products LLC

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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