BISACODYL- bisacodyl suppository 
Geri-Care Pharmaceutical Corp

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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gc bis suppositories

Active Ingredients (in each suppository)

Bisacodyl USP, 10 mg

Purpose

Stimulant Laxative

Uses

  • relieves occasional constipation
  • this product generally produces a bowel movement in 15 minutes to 1 hour

Warnings

For rectal use only.

Do not use

  • when abdominal pain, nausea or vomiting are present

Ask a doctor before use if you have

a sudden change in bowel habits that lasts over a period of 2 weeks

When using this product

you may experience

  • rectal burning
  • mild cramps
  • abdominal discomfort
  • faintness

Stop use and ask a doctor if

  • rectal bleeding occurs
  • you fail to have a bowel movement after using a laxative. These may be signs of a serious condition.
  • you need to use a laxative for more than one week

If pregnant or breast-feeding

ask a health professional before use.

Keep out of reach of children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • tear off one suppository from the strip
  • tear and peel the wrapper in a downward motion
  • continue tearing downward to almost the full length of the suppository (see illustration at the right)
  • gently remove the suppository from the wrapper
  • lie on your side and push suppository, with pointed end first, high into the rectum so it will not slip out
  • retain it for 15 to 20 minutes
  • do not exceed recommended dose
  • if suppository seems soft, place in refrigerator for a short time before use

adults and children 12 years of age and over

1 suppository once daily
children under 12 yearsAsk a doctor

Other information

store at temperatures below 30° C (86° F)

Inactive ingredient

hydrogenated vegetable oil

BISACODYL Laxative Suppository Label

bis

BISACODYL 
bisacodyl suppository
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57896-444(NDC:68784-102)
Route of AdministrationRECTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BISACODYL (UNII: 10X0709Y6I) (DEACETYLBISACODYL - UNII:R09078E41Y) BISACODYL10 mg
Inactive Ingredients
Ingredient NameStrength
FAT, HARD (UNII: 8334LX7S21)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57896-444-122 in 1 CARTON06/01/2005
16 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:57896-444-014 in 1 CARTON06/01/2005
225 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33401/01/200501/01/2023
Labeler - Geri-Care Pharmaceutical Corp (611196254)
Registrant - Geri-Care Pharmaceutical Corp (611196254)
Establishment
NameAddressID/FEIBusiness Operations
Geri-Care Pharmaceutical Corp611196254repack(57896-444)

Revised: 12/2020
 
Geri-Care Pharmaceutical Corp