LAXATIVE- bisacodyl suppository

LAXATIVE by

Drug Labeling and Warnings

LAXATIVE by is a Otc medication manufactured, distributed, or labeled by GRAXCELL PHARMACEUTICAL, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient (in each suppository)

Bisacodyl, 10  mg

Purpose

Stimulant Laxative

Uses

• For relief of occasional constipation
• This product generally produces bowel movement in 15 minutes to 1 hour

Warnings

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

Do not use

• 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.

Ask a doctor

• 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

Stop use and ask a doctor

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

Keep out of reach of children

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

Directions

• Detach one suppository from the strip and remove from foil
• Carefully insert one supoository well into the rectum
• Do not use more than once per day

Other information

store below 30° C (86° F)

Inactive ingredient

hydrogenated vegetable oil

Principal Display panel

GRAXCELL PHARMACEUTICAL, LLC.

NDC: 70795-1010-8/70795-1010-5/70795-1010-1

*Compare to active ingredient in Dulcolax Suppositories

Laxative Suppositories Bisacodyl USP 10mg

For Relief of Occasional Constipation

Gentle and fast Relief

Relieves Constipation Often In 15 Minutes to 1 Hour

8 Comfort Shaped Suppositories

INGREDIENTS AND APPEARANCE

LAXATIVE 
bisacodyl suppository

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70795-1010
Route of Administration	RECTAL

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

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	03/29/2017

Labeler - GRAXCELL PHARMACEUTICAL, LLC (056556923)

Registrant - GRAXCELL PHARMACEUTICAL, LLC (056556923)