BISAC-10 BISACODYL STIMULANT LAXATIVE- bisacodyl suppository

BISAC-10 Bisacodyl Stimulant Laxative by

Drug Labeling and Warnings

BISAC-10 Bisacodyl Stimulant Laxative by is a Otc medication manufactured, distributed, or labeled by GALEN PHARMACEUTICALS LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient (in each suppository)

Bisacodyl 10 mg

Purpose

Laxative

Uses

for relief of occasional constipation
this product generally produces bowel movement in 1/4 to 1 hour

Warnings

For rectal use only

Do not use
laxative products when abdominal pain, nausea or vomiting are present unless directed by a doctor
laxative products for a period longer than 1 week unless directed by a doctor

Ask a doctor before use if you have noticed a sudden change in bowel habits that persists over a period of 2 weeks

When using this product
it may cause  abdominal discomfort faintness
                      rectal burning              mild cramps
                      store at temperatures not above 86°F (30°C)

Stop use and ask a doctor if
rectal bleeding
failure to have a bowel movement which occurs after use of a laxative may indicate a serious condition.

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 of age: 1 suppository, once daily
suppository should be moistened with water before inserting.

Other information

store in well closed containers

Inactive ingredients

polyethylene glycol

Questions? +1-863-434-1782

You may also report serious side effects to this phone number.
Mon - Sun: 24/7

Bisacodyl Stimulant Laxative

Suppositories For Adults

FOR RECTAL USE ONLY

Manufactured by:
Galen Pharmaceuticals Ltd.
334/5 GIDC Estate Waghodia,
Vadodara, Gujarat, India, 391760

Country of Origin: India

Web: www.galenltd.com

Packaging

INGREDIENTS AND APPEARANCE

BISAC-10 BISACODYL STIMULANT LAXATIVE 
bisacodyl suppository

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81440-102
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
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)

Product Characteristics
Color	white	Score
Shape	BULLET (Cylindrical)	Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81440-102-12	1 in 1 BOX	02/15/2021
1		12 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	02/15/2021

Labeler - GALEN PHARMACEUTICALS LIMITED (916655764)

Establishment
Name	Address	ID/FEI	Business Operations
GALEN PHARMACEUTICALS LIMITED		916655764	manufacture(81440-102)