Dulcolax Suppository

Pronunciation

Generic Name: bisacodyl
Dosage Form: suppository

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.

Dulcolax® Suppository

Drug Facts

Active ingredient (in each suppository) Purpose
Bisacodyl USP 10 mg .................................... Stimulant laxative

Uses

  • for temporary relief of occasional constipation and irregularity
  • this product generally produces bowel movement in 15 minutes to 1 hour

Warnings

For rectal use only

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 it may cause stomach discomfort, faintness, rectal burning and mild 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. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

adults and children 12 years of age and over 1 suppository in a single daily dose. Peel open plastic. Insert suppository well into rectum, pointed end first. Retain about 15 to 20 minutes.
children 6 to under 12 years of age 1/2 suppository in a single daily dose
children under 2 years of age ask a doctor

Other information

  • do not store above 30°C (86°F)

Inactive ingredient

hydrogenated vegetable oil

DULCOLAX 
bisacodyl suppository
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0597-0052
Route of Administration RECTAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
bisacodyl (bisacodyl) bisacodyl 10 mg
Product Characteristics
Color WHITE Score     
Shape BULLET Size
Flavor Imprint Code
Contains         
Packaging
# Item Code Package Description
1 NDC:0597-0052-16 4 BLISTER PACK (BLISTER PACK) in 1 CARTON
1 4 SUPPOSITORY (SUPPOSITORY) in 1 BLISTER PACK
2 NDC:0597-0052-28 7 BLISTER PACK (BLISTER PACK) in 1 CARTON
2 4 SUPPOSITORY (SUPPOSITORY) in 1 BLISTER PACK
3 NDC:0597-0052-34 1 BLISTER PACK (BLISTER PACK) in 1 CARTON
3 4 SUPPOSITORY (SUPPOSITORY) in 1 BLISTER PACK
4 NDC:0597-0052-38 2 BLISTER PACK (BLISTER PACK) in 1 CARTON
4 4 SUPPOSITORY (SUPPOSITORY) in 1 BLISTER PACK
5 NDC:0597-0052-44 1 BLISTER PACK (BLISTER PACK) in 1 CARTON
5 1 SUPPOSITORY (SUPPOSITORY) in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part334 04/01/2002
Labeler - Boehringer Ingelheim Pharmaceuticals, Inc. (603175944)
Establishment
Name Address ID/FEI Operations
Istituto De Angeli S.r.l. 436912369 MANUFACTURE
Revised: 11/2010
 
Boehringer Ingelheim Pharmaceuticals, Inc.



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