GENTLE LAXATIVE BISACODYL suppository

Gentle Laxative Bisacodyl by

Drug Labeling and Warnings

Gentle Laxative Bisacodyl by is a Otc medication manufactured, distributed, or labeled by NeilMed Pharmaceuticals Inc, NeilMed Pharmaceuticals Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts : Active ingredient

(in each suppository)
Bisacodyl 10 mg

Drug facts

Purpose
Bisacodyl 10 mg ................................. Stimulant Laxative

Uses

■ for relief of occasional constipation
■ this product generally produces bowel movement in 15 to 60 minutes

Warnings

■ For rectal use only

Do not use

■ when abdominal pain, nausea or vomiting are present
■ for a period longer than 1 week

Ask a doctor before use

if you have noticed a sudden change in bowel habits that lasts over a period of 2 weeks

When using this product

it may cause abdominal discomfort, faintness, rectal bleeding and mild cramps

Stop use and ask a doctor if

■ you have rectal bleeding
■ you fail to have a bowel movement after using this product. This may indicate a serious condition

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.

DOSAGE & ADMINISTRATION

Directions

■ detach one suppository from the strip
■ remove wrapper before inserting into the rectum

adults and children 12 and over : 1 suppository once daily
children 6 to under 12 years : ½ suppository once daily
children under 6 years : do not use

Other information

■ Store at room temperature. Do not exceed 30° C (86° F)
■ Lot No. & Exp. Date: see wrapper or box

Inactive ingredient

hydrogenated vegetable oil

Questions?

Adverse Drug Event Call: 1(877) 477-8633

Tamper evident seal:

Do not use if wrapper on an individual suppository is broken or missing.

INTENDED USE OF THE DEVICE

Prompt, predictable relief from constipation

Package Label

INGREDIENTS AND APPEARANCE

GENTLE LAXATIVE BISACODYL 
gentle laxative bisacodyl suppository

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13709-321
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
PALM KERNEL OIL (UNII: B0S90M0233)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13709-321-01	5 in 1 CARTON	08/24/2023
1		6 in 1 BLISTER PACK
1		1 in 1 CAPSULE; 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	08/24/2023

Labeler - NeilMed Pharmaceuticals Inc (799295915)

Establishment
Name	Address	ID/FEI	Business Operations
NeilMed Pharmaceuticals Inc.		799295915	manufacture(13709-321)