GENTLE LAXATIVE BISACODYL- gentle laxative bisacodyl suppository 
NeilMed Pharmaceuticals Inc

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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NeilMed Gentle Laxative Suppositories Bisacodyl USP 10mg

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.

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.

Prompt, predictable relief from constipation

Package Label

Gentle Laxative Bisacodyl

GENTLE LAXATIVE BISACODYL 
gentle laxative bisacodyl suppository
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13709-321
Route of AdministrationRECTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BISACODYL (UNII: 10X0709Y6I) (DEACETYLBISACODYL - UNII:R09078E41Y) BISACODYL10 mg
Inactive Ingredients
Ingredient NameStrength
PALM KERNEL OIL (UNII: B0S90M0233)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13709-321-015 in 1 CARTON08/24/2023
16 in 1 BLISTER PACK
11 in 1 CAPSULE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33408/24/2023
Labeler - NeilMed Pharmaceuticals Inc (799295915)
Establishment
NameAddressID/FEIBusiness Operations
NeilMed Pharmaceuticals Inc.799295915manufacture(13709-321)

Revised: 8/2023
Document Id: 03b3733a-4d79-149f-e063-6294a90a6518
Set id: 03b3733a-4d78-149f-e063-6294a90a6518
Version: 1
Effective Time: 20230824
 
NeilMed Pharmaceuticals Inc