BISACODYL- bisacodyl suppository

Bisacodyl by

Drug Labeling and Warnings

Bisacodyl by is a Otc medication manufactured, distributed, or labeled by Major Pharmaceuticals, DSC Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each suppository)

Bisacodyl USP, 10mg

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

Do not use

• more than once per day
• for a period longer than one week unless directed by a doctor
• laxative products when abdominal pain, nausia, or vomiting are present unless directed a doctor

Ask a Doctor before using any laxative if you have

• notice a sudden change in bowel habits that lasts more than 2 weeks

When using this product

• may cause stomach discomfort, faintness, rectal burning and mild cramps

Stop use and ask a doctor if

you have rectal bleeding or fail to have a bowel movement after using a laxative. These 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 (1-800-222-1222) right away.

Directions

Adults and children 12 years of age and over - One suppository once daily

Children 6 to under 12 years of age - 1/2 suppository once daily

Children under 6 - Ask a doctor

• Detach one suppository from the strip and remove the foil
• Carefully insert one suppository well into the rectum, pointed end first
• Do not use more than once per day
• Retain about 15 to 20 minutes

Other information

• Storage temperature not to exceed 30ºC (86ºF)
• Indiviually sealed for your protection. Do not use if foil is torn or open.

Inactive ingredients

hydrogenated vegetable oil

Questions or comments?

(800) 616-2471

Major Bisacodyl Suppositories

Major_Bisacodyl_12.jpg

The product package shown above represents a sample of that currently in use. Additional packaging may also be available.

Bisacodyl Suppositories 12ct

Distributed by

Major Pharmaceuticals

Livonia, MI 48152

INGREDIENTS AND APPEARANCE

BISACODYL  
bisacodyl suppository

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0904-7142
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
HYDROGENATED PALM KERNEL OIL (UNII: FM8D1RE2VP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0904-7142-12	2 in 1 CARTON	05/05/2021
1		6 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 0904-7142-60	100 in 1 CARTON	05/05/2021	10/31/2023
2		1 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 Drug	M007	05/05/2021

Labeler - Major Pharmaceuticals (191427277)

Registrant - DSC Laboratories, Inc. (097807374)

Establishment
Name	Address	ID/FEI	Business Operations
DSC Laboratories, Inc.		097807374	manufacture(0904-7142)