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Bisacodyl Enteric Coated by Clinical Solutions Wholesale

Dosage form: tablet, coated
Ingredients: BISACODYL 5mg
Labeler: Clinical Solutions Wholesale
NDC Code: 58118-7927

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 Enteric Coated Tablet

Active ingredient(s)

 Bisacodyl 5mg

Purpose

 Stimulant laxative

Use(s)

 -relieves occasional constipation and irregularity

 -this product generally produces bowel movement in 6 to 12 hours

Warnings

Do not use

 Do not use if you cannot swallow without chewing

Ask a doctor before use if

 -you have a sudden change in bowel habits that lasts more than 2 weeks

-stomach pain, nausea or vomiting

When using this product

 -do not use within 1 hour after taking an antacid or milk

-do not chew or crush tablet(s)

-you may have stomach discomfort, faintness or cramps

Stop use and ask a doctor if

 -you have rectal bleeding or fail to have a bowel movement after use of a laxative. These could be signs of a serious condition.

-you need to use a laxative for more than 1 week

Pregnancy/Breastfeeding

 ask a health professions before use.

Keep out of reach of children

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- take 1 to 3 tablets in a single daily dose

children 6 to under 12 years of age - take 1 tablet in a single daily dose

children under 6 years of age - ask a doctor

Other information

 -store at 25 degrees C (77 degrees F) excursions permitted between 15 degrees-30 degrees C (59 degrees-86 degrees F)

-use by expiration date on package

-protect from excessive humidity

Storage

Inactive ingredients

acacia, bees wax, calcium sulfate, carnauba wax, cellulose, corn starch, D&C Yellow No. 10 lake, FD&C Yellow No. 6 lake, gelatin, lactose, magnesium stearate, pharmaceutical glaze, polyvinyl acetate phthalate, silica gel, sodium starch glycolate, stearinc acid, sugar, talc, titanium dioxide.

Questions

 To Report Adverse Drug Event call: (800) 616-2471

Principal Display Panel

 Bisacodyl Enteric Coated Tabs, USP 5mg

BISACODYL  ENTERIC COATED
bisacodyl tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58118-7927(NDC:0904-7927)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BISACODYL (BISACODYL) BISACODYL5 mg
Inactive Ingredients
Ingredient NameStrength
ACACIA 
CALCIUM SULFATE ANHYDROUS 
ANHYDROUS LACTOSE 
CARNAUBA WAX 
SILICON DIOXIDE 
STARCH, CORN 
D&C YELLOW NO. 10 
FD&C YELLOW NO. 6 
GELATIN 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
AMMONIUM NONOXYNOL-4 SULFATE 
SHELLAC 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
STEARIC ACID 
TALC 
TITANIUM DIOXIDE 
Polyvinyl Acetate Phthalate 
Product Characteristics
ColorORANGEScoreno score
ShapeROUNDSize6mm
FlavorImprint Code5
Contains    
Packaging
#Item CodePackage Description
1NDC:58118-7927-330 TABLET, COATED in 1 BOTTLE
2NDC:58118-7927-660 TABLET, COATED in 1 BOTTLE
3NDC:58118-7927-990 TABLET, COATED in 1 BOTTLE
4NDC:58118-7927-830 TABLET, COATED in 1 BLISTER PACK
5NDC:58118-7927-01 TABLET, COATED in 1 PACKAGE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33410/24/2008
Labeler - Clinical Solutions Wholesale (078710347)
Registrant - Clinical Solutions Wholesale (078710347)
Establishment
NameAddressID/FEIOperations
Clinical Solutions Wholesale078710347REPACK(58118-7927), RELABEL(58118-7927)

 
Clinical Solutions Wholesale

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Medically reviewed on Jul 2, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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