AVEDANA GENTLE LAXATIVE- bisacodyl suppository 
Unipack LLC

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Avedana ® Bisacodyl Suppository

Active Ingredient (in each Suppository)

                                                                   Purpose

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

Uses

Uses - For temporarily relief of occasional constipation and irregularity

-This product generally produces bowel movement in 15 minutes to 1 hour

Warnings

For rectal use only.

Do not use

Do not use - more than once per day - for a period of longer than one week unless directed by a doctor - laxative products when abdominal pain, nausea, or vomiting are present unless directed by a doctor

Ask a doctor

Ask a doctor before use if you have - noticed a sudden change in bowel habits that persists over a period of two weeks

When using this product

When using this product - May cause abdominal discomfort, faintness, rectal burning, and mild cramps

Stop use and ask a doctor

Stop use and ask a doctor if you have rectal bleeding or 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              Children 6 to under 12 years                 Children under 6

One suppository once daily                                         1/2 suppository once daily                    Ask doctor.

-Detach one suppository from the strip and remove from foil - Carefully insert one suppository well into the rectum

-Do not use more than once per day

Other information

Other information - Store at room temperature: 15 o - 30 oC (59 o - 86 oF). Do not exceed 30 oC (86 oF) - Individually sealed for your protection.  Do not use if foil is torn or open

Inactive ingredient

Inactive ingredient  Hydrogenated vegetable oil

Purpose

Stimulant Laxative

Label

Avedana ® Bisacodyl Suppositories

Product Label

AVEDANA GENTLE LAXATIVE 
bisacodyl suppository
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43749-460
Route of AdministrationRECTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BISACODYL (UNII: 10X0709Y6I) (DEACETYLBISACODYL - UNII:R09078E41Y) BISACODYL10 mg
Inactive Ingredients
Ingredient NameStrength
PALM KERNEL OIL (UNII: B0S90M0233)  
Product Characteristics
ColorwhiteScore    
ShapeBULLETSize32mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43749-460-164 in 1 CARTON09/17/2017
1NDC:43749-460-174 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00709/17/2017
Labeler - Unipack LLC (009248480)
Registrant - Unipack LLC (116015769)
Establishment
NameAddressID/FEIBusiness Operations
Unipack LLC009248480manufacture(43749-460)

Revised: 1/2024
Document Id: 0e23b510-8245-a4c7-e063-6294a90a55b4
Set id: e2824884-515a-4a87-bffe-c9d0e97c6c8b
Version: 7
Effective Time: 20240104
 
Unipack LLC