PREMIER VALUE BISACODYL LAXATIVE- bisacodyl suppository suppository 
Chain Drug Consortium

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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Active Ingredient (in each Suppository)

Active Ingredient (in each Suppository)        Purpose

Bisacodyl USP, 10 mg.................................Laxative

Uses

Uses - For relief of occasional constipation -this product generally produces bowel movement in 1/4 hour to 1 hour 

Warnings

For rectal use only.

Do not use

Do not use laxative products

-when abdominal pain, nausea, or vomiting are present - for a period longer than 1 week

Ask a doctor before use if you have

Ask a doctor before use if you have noticed a sudden change in bowel movement

burning and mild cramps

When using this product

When using this product it may cause abdominal discomfort, faintness, rectal burning, and mild cramps

Stop use and ask a doctor

Stop use and ask a doctor if rectal bleeding occurs, or you fail to have bowel movement after using a laxative.  This may indicate a serious condition.

If pregnant or breast-feeding

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

-adults and children 12 years of age and older - detach one suppository from the strip

-remove from wrapper before inserting into the rectum - the rectal suppository dose is one suppository per day or as directed by a doctor - children under 12 years of age consult a doctor.

Other information

Other information

store below 30oC (86oF)

Inactive ingredient

Inactive ingredient  

hydrogenated vegetable oil

Purpose

Active Ingredient (in each Suppository)         Purpose
Bisacodyl USP, 10 mg.................................Laxative

Product Label

Product Label

PREMIER VALUE BISACODYL LAXATIVE 
bisacodyl suppository suppository
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-306
Route of AdministrationRECTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BISACODYL (UNII: 10X0709Y6I) (BISACODYL - UNII:10X0709Y6I) BISACODYL10 mg  in 2000 mg
Inactive Ingredients
Ingredient NameStrength
PALM KERNEL OIL (UNII: B0S90M0233) 1990 mg  in 2000 mg
Product Characteristics
ColorwhiteScore    
ShapeBULLETSize32mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68016-306-092 in 1 PACKAGE
1NDC:68016-306-0840 mg in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33403/25/2015
Labeler - Chain Drug Consortium (101668460)
Establishment
NameAddressID/FEIBusiness Operations
Unipack, Inc.009248480manufacture(68016-306)

Revised: 3/2015
Document Id: 86386976-d5c5-4d5e-bab6-28825037e677
Set id: b98997b8-1158-4d88-b3ad-da767f203bbf
Version: 1
Effective Time: 20150325
 
Chain Drug Consortium