Label at a glance#

ProductBiscolax Laxative

Active ingredientBISACODYL

Label structure11 sections

Indications and uses

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

Dosage and administration

adults and children 12 years of age and over 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 of age 1/2 suppository in a single daily dose children under 6 years of age Do not use

Storage and handling

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

Contacts and useful links#

PhoneLabel contact(800) 616-2471

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each suppository)

OTC - ACTIVE INGREDIENT SECTION

Bisacodyl USP 10 mg

Purpose

OTC - PURPOSE SECTION

Stimulant Laxative

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

For rectal use only

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

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

OTC - WHEN USING SECTION

When using this product it may cause abdominal discomfort, faintness, rectal burning and mild cramps

Stop use and ask a doctor if

OTC - STOP USE SECTION

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

adults and children 12 years of age and over	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 of age	1/2 suppository in a single daily dose
children under 6 years of age	Do not use

Other information

STORAGE AND HANDLING SECTION

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

Inactive ingredient

INACTIVE INGREDIENT SECTION

hydrogenated vegetable oil

Questions or Comments?

OTC - QUESTIONS SECTION

(800) 616-2471

SPL UNCLASSIFIED SECTION

Distributed by:
MAJOR ^® PHARMACEUTICALS
17177 N Laurel Park Drive, Suite 233
Livonia, MI 48152 USA

PRINCIPAL DISPLAY PANEL - 12 Suppository Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MAJOR^®

NDC 0904-5058-12

Biscolax™
Laxative

Doctor Recommended Ingredient
Fast Dependable Relief

Bisacodyl, USP 10 mg.
12 SUPPOSITORIES

Compare to active ingredient of
Dulcolax ^® Suppositories*

PRINCIPAL DISPLAY PANEL - 12 Suppository Carton

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0904-5058-12	EA - Each	0904-5058	bd6e8652-e593-4c48-8ccc-a38eab19f577	1	2013-02-13
0904-5058-60	EA - Each	0904-5058	5b0dd18d-0f92-4c5a-a5e2-2cca68d94501	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Bisacodyl	ACTIVE INGREDIENT	10X0709Y6I	1
Bisacodyl	ACTIVE MOIETY	10X0709Y6I	1
Fat, Hard	INACTIVE INGREDIENT	8334LX7S21	1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 4 matching rows.

Biscolax Laxative
Bisacodyl
FAT, HARD
DEACETYLBISACODYL

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
0904-5058	0904-5058-60, 0904-5058-12

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
FAT, HARD	8334LX7S21	IACT
BISACODYL	10X0709Y6I	ACTIB

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 2 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
Fat, Hard	HARD FAT	8334LX7S21	SUPPOSITORY / RECTAL		7657 mg	Exact identifier — unii candidate 2 equally ranked IID candidates
Fat, Hard	HARD FAT	8334LX7S21	CAPSULE / ORAL		153 mg	Exact identifier — unii candidate 2 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
93632ad1-64aa-845f-e053-2a95a90ae64c			dcd8ac04-3a65-4b39-87bb-98f266ac1e9c	2019-09-25	Warnings	Exact identifier spl id: 93632ad1-64aa-845f-e053-2a95a90ae64c spl set id: dcd8ac04-3a65-4b39-87bb-98f266ac1e9c

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.