Active Ingredient (in each suppository)

Bisacodyl, 10 mg

Purpose

Stimulant Laxative

For rectal use only. May cause abdominal discomfort, faintness, rectal burning, and mild cramps.

more than once per day
for a period longer than one week unless directed by a doctor
laxative products when abdominal pain, nausea, or vomitting are present unless directed by a doctor
if sealed film around the suppository is torn, damaged, or open.

before use if you have noticed a sudden change in bowel habits that persist over a period of two weeks
if you are pregnant or nursing a baby

if you have rectal bleeding or fail to have a bowel movement after using a laxative. This may indicate a serious condition.

If swallowed, get medical help or contact a Poison Control Center right away.

Table

store below 30° C (86° F)

hydrogenated vegetable oil

Label 1

Label 2

Label 3

LAXATIVE
bisacodyl suppository

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

Ingredient Name	Strength
Inactive Ingredients
FAT, HARD (UNII: 8334LX7S21)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70795-1010-8	8 in 1 BOX	03/29/2017
1		1 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC:70795-1010-5	50 in 1 BOX	04/22/2017
2		1 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC:70795-1010-1	100 in 1 PACKAGE	04/22/2017
3		1 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M007	03/29/2017

Labeler - GRAXCELL PHARMACEUTICAL, LLC (056556923)