BISCOLAX LAXATIVE- bisacodyl suppository 
Major

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Biscolax™ Laxative

Drug Facts

Active ingredient (in each suppository)

Bisacodyl USP 10 mg

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

Ask a doctor before use if you have

  • stomach pain, nausea or vomiting
  • a sudden change in bowel habits that lasts more than 2 weeks

When using this product it may cause abdominal discomfort, faintness, rectal burning and mild cramps

Stop use and ask a doctor if

  • you have rectal bleeding or no bowel movement after using this product. These could be signs of a serious condition.
  • you need to use a laxative for more than 1 week

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.

Directions

adults and children 12 years of age and over1 suppository in a single daily dose. Peel open plastic wrapper. Insert suppository well into rectum, pointed end first. Retain about 15 to 20 minutes.
children 6 to under 12 years of age1/2 suppository in a single daily dose
children under 6 years of ageDo not use

Other information

  • store at 20-25°C (68-77°F)
  • Lot No. & Exp. Date: see wrapper or box

Inactive ingredient

hydrogenated vegetable oil

Questions or Comments?

(800) 616-2471

Distributed by:
MAJOR ® PHARMACEUTICALS
17177 N Laurel Park Drive, Suite 233
Livonia, MI 48152 USA

PRINCIPAL DISPLAY PANEL - 12 Suppository Carton

MAJOR®

NDC 0904-5058-12

Biscolax
Laxative

Doctor Recommended Ingredient
Fast Dependable Relief

Bisacodyl, USP 10 mg.
12 SUPPOSITORIES

Compare to active ingredient of
Dulcolax ® Suppositories*

PRINCIPAL DISPLAY PANEL - 12 Suppository Carton
BISCOLAX LAXATIVE 
bisacodyl suppository
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-5058
Route of AdministrationRECTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BISACODYL (UNII: 10X0709Y6I) (DEACETYLBISACODYL - UNII:R09078E41Y) BISACODYL10 mg
Inactive Ingredients
Ingredient NameStrength
FAT, HARD (UNII: 8334LX7S21)  
Product Characteristics
ColorwhiteScoreno score
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0904-5058-60100 in 1 CARTON; Type 0: Not a Combination Product08/24/201202/28/2021
2NDC:0904-5058-1212 in 1 CARTON; Type 0: Not a Combination Product08/24/201211/30/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33408/24/201202/28/2021
Labeler - Major (191427277)

Revised: 9/2019
 
Major