GENTLE LAXATIVE- bisacodyl suppository suppository

Avedana Gentle Laxative by

Drug Labeling and Warnings

Avedana Gentle Laxative by is a Otc medication manufactured, distributed, or labeled by Unipack LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 suppositry well into the rectum

-Do not use more than once per day

Other information

Other information - Store at room temperature: 15o - 30oC (59o - 86oF). Do not exceed 30oC (86oF) - 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

INGREDIENTS AND APPEARANCE

GENTLE LAXATIVE 
bisacodyl suppository suppository

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43749-460
Route of Administration	RECTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BISACODYL (UNII: 10X0709Y6I) (DEACETYLBISACODYL - UNII:R09078E41Y)	BISACODYL	10 mg  in 2000 mg

Inactive Ingredients
Ingredient Name	Strength
PALM KERNEL OIL (UNII: B0S90M0233)	1990 mg  in 2000 mg

Product Characteristics
Color	white	Score
Shape	BULLET	Size	32mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43749-460-17	4 in 1 CARTON	09/17/2017
1	NDC: 43749-460-16	40 mg in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	09/17/2017

Labeler - Unipack, Inc. (009248480)

Establishment
Name	Address	ID/FEI	Business Operations
Unipack, Inc.		009248480	manufacture(43749-460)