BISACODYL- bisacodyl suppository 
Geritrex LLC

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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Bisacodyl Suppositories

Drug Facts

Active ingredient (in each suppository) Purpose

Bisacodyl USP 10 mg ................................ Stimulant laxative

Uses

relieves occasional constipation.

this product generally produces a bowel movement in 15 minutes to 1 hour.

Directions

tear off one suppository from the strip.
tear and peel the wrapper in 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 and over 1 suppository once daily.
Children under 12 years Ask a doctor.

Adults and children 12 years and over 1 suppository once daily.
Children under 12 years Ask a doctor.

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 you have rectal bleeding. you fill 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.

INACTIVE INGREDIENT

hydrogenated vegetable oil

STORAGE

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

OTC - KEEP OUT OF REACH OF CHILDREN

If swallowed, get medical help or contact a poison control center right away.

package label

BISACODYL 
bisacodyl suppository
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54162-006
Route of AdministrationRECTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BISACODYL (UNII: 10X0709Y6I) (BISACODYL - UNII:10X0709Y6I) BISACODYL0.01 g  in 2 g
Inactive Ingredients
Ingredient NameStrength
HYDROGENATED SOYBEAN OIL (UNII: A2M91M918C)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54162-006-012 g in 1 BOX, UNIT-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33407/31/2015
Labeler - Geritrex LLC (112796248)

Revised: 1/2016
Document Id: a78bd90b-68ba-4e55-90fa-683f377f0295
Set id: a42b62b3-3b0a-4c11-96b3-8635e8c20ae2
Version: 4
Effective Time: 20160107
 
Geritrex LLC