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Gentle Laxative by Kareway Product, Inc.

Medically reviewed on February 15, 2018

Dosage form: tablet, coated
Ingredients: BISACODYL 5mg
Labeler: Kareway Product, Inc.
NDC Code: 67510-0171

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.

Drug facts

Active ingredient (in each tablet)

Bisacodyl USP 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)
  • do not use within 1 hour after taking an antacid or milk
  • it may cause stomach discomfort, faintness and cramps

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 of age and over
1 to 3 tablets in a single daily dose
children 6 to under 12 years of age
1 tablet in a single daily dose
children under 6 years of age
ask a doctor

Other information
  • store at 20° - 25°C (68° - 77°F)
  • protect from excessive humidity
  • blister packaged for your protection. Do not use if individual seals are broken.

Inactive ingredients

acacia, carnauba wax, corn starch, gelatin, glycerin esters of fatty acids, hypromellose phthalate 200731, lactose hydrate, magnesium stearate, polyethylene glycol 400, povidone, precipitated calcium carbonate, sucrose, talc, titanium oxide, yellow no. 4

Package label

Gentle Laxative

GENTLE LAXATIVE 
biisacodyl tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67510-0171
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BISACODYL (BISACODYL) BISACODYL5 mg
Inactive Ingredients
Ingredient NameStrength
ACACIA 
CARNAUBA WAX 
STARCH, CORN 
GELATIN 
HYPROMELLOSE PHTHALATE (24% PHTHALATE, 55 CST) 
LACTOSE MONOHYDRATE 
MAGNESIUM STEARATE 
POLYETHYLENE GLYCOL 400 
POVIDONE 
CALCIUM CARBONATE 
SUCROSE 
TALC 
TITANIUM DIOXIDE 
Product Characteristics
ColoryellowScoreno score
ShapeROUNDSize7mm
FlavorImprint CodeBIS
Contains    
Packaging
#Item CodePackage Description
1NDC:67510-0171-22 BLISTER PACK (BLISTER PACK) in 1 BOX
110 TABLET, COATED (TABLET) in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33402/15/2012
Labeler - Kareway Product, Inc. (121840057)

 
Kareway Product, Inc.

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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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