BISCOLAX- bisacodyl suppository
Rugby Laboratories, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Biscolax

Drug Facts

Active ingredient (in each suppository)

Bisacodyl USP 10 mg

Purpose

Stimulant laxative

Uses

for temporary relief of occasional constipation and irregularity
this product generally produces bowel movement in 15 minutes to 1 hour

Warnings

For rectal use only

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 it may cause abdominal discomfort, faintness, rectal burning 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. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

adults and children 12 years and older	1 suppository in a single daily dose. Peel open plastic wrapper. Insert suppository well into rectum, pointed end first. Retain about 15 to 20 minutes.
children 6 to under 12 years	1/2 suppository in a single daily dose
children under 6 years	ask a doctor

Other information

store at room temperature 20 - 25°C (68-77°F).
Lot No. & Exp. Date: see wrapper or box

Inactive ingredient

hydrogenated vegetable oil

Questions or comments?

1-800-645-2158

Distributed by:
Rugby Laboratories
17177 N Laurel Park Drive, Suite 233
Livonia, MI 48152

PRINCIPAL DISPLAY PANEL - 10 mg Suppository Carton

Rugby®

NDC 0536-1355-01

COMPARE TO
ACTIVE INGREDIENT IN
DULCOLAX®*

Laxative Suppositories
Stimulant Laxative

100 RECTAL SUPPOSITORIES

TAMPER EVIDENT: DO NOT ACCEPT IF SEALED WRAPPER
AROUND SUPPOSITORIES IS TORN OR OPEN

Bisacodyl
USP, 10 mg

Principal Display Panel - 10 mg Suppository Carton

BISCOLAX
bisacodyl suppository

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0536-1355
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)

Product Characteristics
Color	white (White to off white opaque)	Score	no score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0536-1355-01	100 in 1 CARTON; Type 0: Not a Combination Product	09/03/2002	01/31/2021
2	NDC:0536-1355-12	12 in 1 CARTON; Type 0: Not a Combination Product	09/03/2002	01/31/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part334	09/03/2002	01/31/2021

Labeler - Rugby Laboratories, Inc. (079246066)

Revised: 9/2019

Document Id: 936414cb-0ab7-c576-e053-2a95a90a51f9

Set id: 2a1b271e-ae17-4284-bfa1-4d0e3c75fcc3

Version: 4

Effective Time: 20190925

Rugby Laboratories, Inc.