BISCOLAX- bisacodyl suppository

Biscolax by

Drug Labeling and Warnings

Biscolax by is a Otc medication manufactured, distributed, or labeled by Rugby Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

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

INGREDIENTS AND APPEARANCE

BISCOLAX 
bisacodyl suppository

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

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	09/03/2002	01/31/2021

Labeler - Rugby Laboratories, Inc. (079246066)