BISACODYL- bisacodyl suppository 
Padagis US 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, USP Drug Facts

Active ingredient (in each suppository)

Bisacodyl USP 10 mg

Purpose

Stimulant laxative

Use

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

Ask a doctor or pharmacist before use if you are

taking any other drug. Take this product two or more hours before or after other drugs. Laxatives may affect how other drugs work.

When using this product

it may cause stomach discomfort, faintness, rectal burning and milk cramps

Stop use and ask a doctor if

you have rectal bleeding or fail to have a bowel movement after use of a laxative because 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. (1-800-222-1222)

Directions

adults and children 12 years of age and over

1 suppository in a single daily dose. Pull apart foil. Insert suppository well into rectum, pointed end first. Retain about 15 to 20 minutes.

children 6 to under 12 years of age

½ suppository in a single daily dose

children under 6 years of age

ask a doctor

Other information

store at 20-25°C (68-77°F)

Inactive ingredients

hydrogenated vegetable oil

Questions or comments?

1-800-719-9260

Package/Label Principal Display Panel

NDC 0574-7050-12

Bisacodyl Suppositories, USP

10 mg

Stimulant Laxative

Easy-open plastic packets

Tapered shape for easy insertion

UNIT DOSE

12 Suppositories

bisacodyl
BISACODYL 
bisacodyl suppository
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0574-7050
Route of AdministrationRECTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BISACODYL (UNII: 10X0709Y6I) (DEACETYLBISACODYL - UNII:R09078E41Y) BISACODYL10 mg
Inactive Ingredients
Ingredient NameStrength
COTTONSEED OIL (UNII: H3E878020N)  
Product Characteristics
ColorWHITE (white to cream) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0574-7050-1212 in 1 CARTON09/01/1990
11 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:0574-7050-5050 in 1 CARTON09/01/1990
21 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 finalpart33409/01/1990
Labeler - Padagis US LLC (967694121)

Revised: 11/2021
Document Id: 06214150-2221-462b-a0ac-5a5a8a257c13
Set id: 7eada0fc-5f83-43da-a56f-b0f537298208
Version: 4
Effective Time: 20211115
 
Padagis US LLC