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Quality Choice Gentle Laxative

Dosage form: suppository
Ingredients: BISACODYL 10mg in 2000mg
Labeler: Chain Drug Marketing Association
NDC Code: 63868-360

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

Bisacodyl USP, 10 mg


Purpose

Stimulant Laxative

Uses
  • For relief of occasional constipation and irregularity
  • -This product generally produces bowel movement in 15 minutes to 1 hour

Warnings For rectal use only.

  • stomach pain, nausea or vomiting
  • noticed a sudden change in bowel habits that persists over a period of two weeks

When using this product

May cause abdominal discomfort, faintness, rectal burning, and mild cramps

Stop use and ask a doctor if

  • if you have rectal bleeding or fail to have bowel movement after using a laxative. This may indicate 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

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Adults and children 12 years of age and older                           Children 6 to under 12 years                     Children under 6

One suppository once daily                                                        1/2 suppository once daily                        Ask doctor.

-Detach one suppository from the strip and remove from foil - Carefully insert one suppositry well into the rectum

-Do not use more than once per day

Other Information
  •  do not store above 30°C (86°F)

Inactive Ingredients

hydrogenated vegetable oil

QUALITY CHOICE GENTLE LAXATIVE 
bisacodyl suppository
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-360
Route of AdministrationRECTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BISACODYL (DEACETYLBISACODYL) BISACODYL10 mg  in 2000 mg
Inactive Ingredients
Ingredient NameStrength
FAT, HARD1990 mg  in 2000 mg
Product Characteristics
ColorwhiteScore    
ShapeBULLETSize34mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:63868-360-082 BLISTER PACK in 1 CARTON
140 mg in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33402/13/2015
Labeler - Chain Drug Marketing Association (011920774)
Registrant - Reese Pharmaceutical Co (004172052)
Establishment
NameAddressID/FEIOperations
Reese Pharmaceutical Co004172052relabel(63868-360), repack(63868-360)
Establishment
NameAddressID/FEIOperations
Biopharm801652546manufacture(63868-360)

 
Chain Drug Marketing Association

Medically reviewed on Aug 30, 2017

Further information

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

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