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NDC 63868-0328-08 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 Chain Drug Marketing Association, Inc.. 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: 63868-0328-08
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Bisacodyl Rectal

Product Information

NDC	63868-0328
Product ID	63868-328_c2b0a386-1169-8bd5-e053-2995a90a2eec
Associated GPIs	46200010005205 46200010000610
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	Chain Drug Marketing Association, Inc.
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 63868-0328-08 (63868032808)

Pricing Information
NDC Package Code	63868-328-08
Billing NDC	63868032808
Package	8 BLISTER PACK in 1 BOX (63868-328-08) / 1 SUPPOSITORY in 1 BLISTER PACK
Marketing Start Date	2021-05-18
NDC Exclude Flag	N
Price Per Unit	0.29694
Pricing Unit	EA
Effective Date	2022-11-23
NDC Description	QC GENTLE LAXATIVE 10 MG SUPP
Pharmacy Type Indicator	C/I
OTC	Y
Explanation Code	1
Classification for Rate Setting	G
As of Date	2022-11-23

This pricing file, entitled the NADAC (National Average Drug Acquisition Cost) files, provide state Medicaid agencies with covered outpatient drug prices by averaging survey invoice prices from retail community pharmacies across the United States. These pharmacies include independent retail community pharmacies and chain pharmacies. The prices are updated on a weekly and monthly basis

Standard Product Labeling (SPL)/Prescribing Information SPL aa8e1cb0-cc92-47e8-8a69-f43da94bede3 Details

Active ingredient

Active ingredient (in each Suppository)

Bisacodyl, 10 mg

Purpose

Stimulant Laxative

SPL UNCLASSIFIED SECTION

Keep out of reach of children.

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

Uses

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

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
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 persists 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.

Directions

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

Store at room temperature: 15° - 30° C (59° - 86° F) Do not exceed 30° C (86° F)
Individually sealed for your protection. Do not use if foil is torn or open.

Inactive ingredients

hydrogenated vegetable oil

Warnings

For rectal use only.

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LAXATIVE

bisacodyl suppository

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63868-328
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:63868-328-08	8 in 1 BOX	05/18/2021
1		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	12/21/2007

Labeler - Chain Drug Marketing Association, Inc. (011920774)

Registrant - Acino Products, LLC (019385518)

Name	Address	ID/FEI	Business Operations
Establishment
Acino Products, LLC		019385518	manufacture(63868-328)

Revised: 5/2021

Document Id: c2b0a386-1169-8bd5-e053-2995a90a2eec

Set id: aa8e1cb0-cc92-47e8-8a69-f43da94bede3

Version: 3

Effective Time: 20210519