LAXATIVE- bisacodyl suppository

Laxative by

Drug Labeling and Warnings

Laxative by is a Otc medication manufactured, distributed, or labeled by Chain Drug Marketing Association, Inc., Acino Products, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug facts Active ingredient

Active ingredient (in each Suppository)

Bisacodyl, 10 mg

Purpose

Stimulant 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 generally produces bowel movement in 15 minutes to 1 hour

Do not use

• more than once per day
• for a period of longer than one week unless directed by a doctor
• laxative products when abdominal pain, nausea, or vomiting are present unless directed by a doctor
• if sealed film around the suppository is torn, damaged, or open
  

Ask a doctor

• before use if you have noticed a sudden change in bowel habits that persists over a period of two weeks
• if you are pregnant or nursing a baby
  

Stop use and ask a doctor

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

Directions

• Detach one suppository from the strip and remove from foil
• Carefully insert one suppository well into the rectum
• Do not use more than once per day
  

Other information

• Store at room temperature: 15° - 30° C (59° - 86° F) Do not exceed 30° C (86° F)
• Individually sealed for your protection. Do not use if foil is torn or open.
  

Inactive ingredients

hydrogenated vegetable oil

Warnings

For rectal use only.

May cause abdominal discomfort, faintness, rectal burning, and mild cramps.

Laxative Suppositories Product Label

For Relief of Occasional Constipation

NDC: 63868-328-08

*Compare to the active ingredient in  Dulcolax®

QC QUALITY CHOICE

Laxative
Suppositories

Gentle and Fast Relief

Bisacodyl USP 10 mg
Relieves Constipation Often in 15 Minutes to 1 Hour

8 Comfort Shaped Suppositories

SATISFACTION GUARANTEED QC 100%

Distributed by C.D.M.A. Inc.©
43157 W. Nine Mile
Novi, MI 48376-0995
www.qualitychoice.com
Questions: 248-449-9300

TAMPER EVIDENT: Individually sealed in foil for your protection. Do not use if torn or open.

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

INGREDIENTS AND APPEARANCE

LAXATIVE 
bisacodyl suppository

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63868-328
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: 63868-328-08	8 in 1 BOX
1		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	12/21/2007

Labeler - Chain Drug Marketing Association, Inc. (011920774)

Registrant - Acino Products, LLC (019385518)

Establishment
Name	Address	ID/FEI	Business Operations
Acino Products, LLC		019385518	manufacture(63868-328)