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NDC 70795-1010-08 LAXATIVE 10 mg/1 Details

LAXATIVE 10 mg/1

LAXATIVE is a RECTAL SUPPOSITORY in the HUMAN OTC DRUG category. It is labeled and distributed by GRAXCELL PHARMACEUTICAL, LLC. The primary component is BISACODYL.

MedlinePlus Drug Summary

Rectal bisacodyl is used on a short-term basis to treat constipation. It also is used to empty the bowels before surgery and certain medical procedures. Bisacodyl is in a class of medications called stimulant laxatives. It works by increasing activity of the intestines to cause a bowel movement.

Related Packages: 70795-1010-08
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Bisacodyl Rectal

Product Information

NDC	70795-1010
Product ID	70795-1010_d3adbcb3-74ef-1ee2-e053-2995a90acbcc
Associated GPIs	46200010005205
GCN Sequence Number	002944
GCN Sequence Number Description	bisacodyl SUPP.RECT 10 MG RECTAL
HIC3	Q3S
HIC3 Description	LAXATIVES, LOCAL/RECTAL
GCN	08731
HICL Sequence Number	001301
HICL Sequence Number Description	BISACODYL
Brand/Generic	Generic
Proprietary Name	LAXATIVE
Proprietary Name Suffix	n/a
Non-Proprietary Name	BISACODYL
Product Type	HUMAN OTC DRUG
Dosage Form	SUPPOSITORY
Route	RECTAL
Active Ingredient Strength	10
Active Ingredient Units	mg/1
Substance Name	BISACODYL
Labeler Name	GRAXCELL PHARMACEUTICAL, LLC
Pharmaceutical Class	Increased Large Intestinal Motility [PE], Stimulant Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part334
Listing Certified Through	2023-12-31

Package

Package Images

NDC 70795-1010-08 (70795101008)

Pricing Information	N/A
NDC Package Code	70795-1010-8
Billing NDC	70795101008
Package	8 BLISTER PACK in 1 BOX (70795-1010-8) / 1 SUPPOSITORY in 1 BLISTER PACK
Marketing Start Date	2017-03-29
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 5a65d4ab-447f-42bb-b38d-070db523b806 Details

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

INGREDIENTS AND APPEARANCE

LAXATIVE

bisacodyl suppository

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

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 not final	part334	03/29/2017

Labeler - GRAXCELL PHARMACEUTICAL, LLC (056556923)

Revised: 12/2021

Document Id: d3adbcb3-74ef-1ee2-e053-2995a90acbcc

Set id: 5a65d4ab-447f-42bb-b38d-070db523b806

Version: 5

Effective Time: 20211221