BISACODYL by Acino Products, LLC BISACODYL suppository

BISACODYL by

Drug Labeling and Warnings

BISACODYL by is a Otc medication manufactured, distributed, or labeled by Acino Products, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts Active Ingredients (per suppository)

Bisacodyl USP, 10  mg

Purpose

Laxative

Keep out of reach of children

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

Uses

• for relief of occasional constipation
• this product usually 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
• for a period longer than one week
  

Ask a doctor before use if you have

noticed a sudden change in bowel habits that persist over a period of 2 weeks

When using this product

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

Stop use and ask a doctor if

rectal bleeding occurs, or you fail to have a bowel movement after using a laxative. This may indicate a serious condition.

If pregnant or breast-feeding

ask a health professional before use.

Directions

• adults and children 12 years of age and older
• detach one suppository from the strip
• remove from wrapper before inserting into the rectum
• the rectal suppository dose is one suppository per day or as directed by a doctor
• children under 12 years of age consult a doctor
  

Other information

store below 30° C (86° F)

Inactive ingredient

hydrogenated vegetable oil

BISACODYL Laxative Suppository Label

Acino Products

NDC: 68784-102-16

COMPARE TO THE ACTIVE INGREDIENT IN DULCOLAX® SUPPOSITORIES

BISACODYL
Laxative Suppositories

FAST RELIEF OF TEMPORARY CONSTIPATION OFTEN IN 15 MINUTES TO 1 HOUR

16 SUPPOSITORIES (10 mg each)

TAMPER-EVIDENT: FOR YOUR SAFETY, SUPPOSITORIES ARE PACKED IN TAMPER-EVIDENT SEALED WRAPPER.
DO NOT USE IF WRAPPER IS TORN OR OPEN.

This product is not manufactured or distributed by Boehringer Ingelheim Consumer Healthcare Products, Inc., owner of the registered trademark Dulcolax®

DISTRIBUTED BY
ACINO PRODUCTS, LLC
681 MAIN ST. BLDG. 27
BELLEVILLE, NJ 07109

MADE IN USA

INGREDIENTS AND APPEARANCE

BISACODYL 
bisacodyl suppository

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68784-102
Route of Administration	RECTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BISACODYL (UNII: 10X0709Y6I) (BISACODYL - UNII:10X0709Y6I)	BISACODYL	10 mg

Inactive Ingredients
Ingredient Name	Strength
FAT, HARD (UNII: 8334LX7S21)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68784-102-08	8 in 1 BOX
1		1 in 1 BLISTER PACK
2	NDC: 68784-102-12	12 in 1 BOX
2		1 in 1 BLISTER PACK
3	NDC: 68784-102-16	16 in 1 BOX
3		1 in 1 BLISTER PACK
4	NDC: 68784-102-01	100 in 1 BOX
4		1 in 1 BLISTER PACK

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	01/01/2005

Labeler - Acino Products, LLC (019385518)

Registrant - Acino Products, LLC (019385518)

Establishment
Name	Address	ID/FEI	Business Operations
Acino Products, LLC		019385518	manufacture(68784-102)