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NDC 24385-0903-63 Laxative 5 mg/1 Details

Laxative 5 mg/1

Laxative is a ORAL TABLET, COATED in the HUMAN OTC DRUG category. It is labeled and distributed by AmerisourceBergen Drug Corporation (Good Neighbor Pharmacy) 24385. The primary component is BISACODYL.

MedlinePlus Drug Summary

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: 24385-0903-63
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Bisacodyl

Product Information

NDC	24385-0903
Product ID	24385-903_f5edba62-afea-49d4-8e2c-12369eb9ea0a
Associated GPIs	46200010000610
GCN Sequence Number	002947
GCN Sequence Number Description	bisacodyl TABLET DR 5 MG ORAL
HIC3	D6S
HIC3 Description	LAXATIVES AND CATHARTICS
GCN	08762
HICL Sequence Number	001301
HICL Sequence Number Description	BISACODYL
Brand/Generic	Generic
Proprietary Name	Laxative
Proprietary Name Suffix	Enteric Coated
Non-Proprietary Name	Bisacodyl
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET, COATED
Route	ORAL
Active Ingredient Strength	5
Active Ingredient Units	mg/1
Substance Name	BISACODYL
Labeler Name	AmerisourceBergen Drug Corporation (Good Neighbor Pharmacy) 24385
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	n/a

Package

Package Images

NDC 24385-0903-63 (24385090363)

Pricing Information
NDC Package Code	24385-903-63
Billing NDC	24385090363
Package	1 BLISTER PACK in 1 CARTON (24385-903-63) / 25 TABLET, COATED in 1 BLISTER PACK
Marketing Start Date	2011-10-24
NDC Exclude Flag	N
Price Per Unit	0.03773
Pricing Unit	EA
Effective Date	2022-09-21
NDC Description	LAXATIVE EC 5 MG TABLET
Pharmacy Type Indicator	C/I
OTC	Y
Explanation Code	1
Classification for Rate Setting	G
As of Date	2022-09-28

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 839cef2f-3f3c-465b-9932-5d25b39a0f6f Details

Active ingredient (in each tablet)

Bisacodyl USP 5 mg

Purpose

Stimulant laxative

Use

for temporary relief of occasional constipation and irregularity
this product generally produces a bowel movement in 6 to 12 hours

Warnings

Do not use

if you cannot swallow without chewing.

Ask a doctor before use if you have

stomach pain, nausea or vomiting
a sudden change in bowel habits that lasts more than 2 weeks

When using this product

do not chew or crush tablet(s)
do not use within 1 hour after taking an antacid or milk
it may cause stomach discomfort, faintness and cramps

Stop use and ask a doctor if

you have rectal bleeding or no bowel movement after using this product. These could be signs of a serious condition.
you need to use a laxative for more than 1 week

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

•take with a glass of water

adults and children 12 years of age and over	take 1 to 3 tablets in a single daily dose
children 6 to under 12 years of age	take 1 tablet in a single daily dose
children under 6 years of age	ask a doctor

Other information

store between 20º-25ºC (68º-77ºF)

Inactive ingredients

acacia, anhydrous calcium sulfate, anhydrous lactose, carnauba wax, colloidal silicon dioxide, corn starch, D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, gelatin, iron oxide, iron oxide black, iron oxide yellow, magnesium stearate, microcrystalline cellulose, polyethylene glycol (PEG) 400, polyvinyl acetate phthalate, povidone, shellac, sodium starch glycolate, stearic acid, sugar, talc, titanium dioxide

Questions or Comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

*Compare to Dulcolax® active ingredient

Laxative

Bisacodyl, 5 mg

Gentle, Predictable Overnight Relief

Enteric coated tablets

*This product is not manufactured or distributed by Boehringer Ingelheim Pharmaceuticals, Inc., distributor of Dulcolax® Laxative.

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

Distributed By AmerisourceBergen

1300 Morris Drive, Chesterbrook, PA 19087

Visit us at www.mygnp.com

Package Label

Good Neighbor Pharmacy Laxative

INGREDIENTS AND APPEARANCE

LAXATIVE ENTERIC COATED

bisacodyl tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:24385-903
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BISACODYL (UNII: 10X0709Y6I) (DEACETYLBISACODYL - UNII:R09078E41Y)	BISACODYL	5 mg

Ingredient Name	Strength
Inactive Ingredients
ACACIA (UNII: 5C5403N26O)
CALCIUM SULFATE ANHYDROUS (UNII: E934B3V59H)
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
CARNAUBA WAX (UNII: R12CBM0EIZ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STARCH, CORN (UNII: O8232NY3SJ)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
ALUMINUM OXIDE (UNII: LMI26O6933)
GELATIN (UNII: 2G86QN327L)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
Polyvinyl Acetate Phthalate (UNII: 58QVG85GW3)
POVIDONE (UNII: FZ989GH94E)
SHELLAC (UNII: 46N107B71O)
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)
STEARIC ACID (UNII: 4ELV7Z65AP)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SUCROSE (UNII: C151H8M554)

Product Characteristics
Color	orange, yellow	Score	no score
Shape	ROUND	Size	6mm
Flavor		Imprint Code	TCL003
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:24385-903-63	1 in 1 CARTON	10/24/2011	12/27/2024
1		25 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	10/24/2011	12/27/2024

Labeler - AmerisourceBergen Drug Corporation (Good Neighbor Pharmacy) 24385 (007914906)

Revised: 9/2022

Document Id: f5edba62-afea-49d4-8e2c-12369eb9ea0a

Set id: 839cef2f-3f3c-465b-9932-5d25b39a0f6f

Version: 6

Effective Time: 20220921