BISACODYL- bisacodyl suppository 
Rising Pharma Holdings, 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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Bisacodyl USP Suppositories 10 mg

Drug Facts

Active ingredient (in each suppository)

Bisacodyl USP, 10 mg

Purpose

Stimulant Laxative

Use

Warnings

For rectal use only

Ask a doctor before use if you have

When using this product you may experience stomach discomfort, faintness, rectal burning and mild cramps

Stop use and ask a doctor if

If pregnant or breast-feeding, ask 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 over

1 suppository in a single daily dose. Peel open plastic. Insert suppository

well into rectum, pointed end first. Retain about 15 to 20 minutes

children 6 to under 12 years1/2 suppository in a single daily dose
children under 6 yearsDo not use

Other information

Inactive ingredient hard fat

Questions or Comments? Call 1-844-474-7464

TAMPER EVIDENT: DO NOT USE IF SEALED WRAPPER AROUND SUPPOSITORIES IS BROKEN OR MISSING

Distributed by:
Rising Pharma Holdings, Inc.
East Brunswick, NJ 08816

Made in India

CODE NO.: MH/DRUGS/25-KD/724

Issued: 08/2023

NDC 57237-327-21 (3 blisters of 4 suppositories)

Bisacodyl USP Suppositories 10 mg

Stimulant Laxative

Gentle, Predictable, Fast Relief

DO NOT SWALLOW

Bisc-supp-01

NDC 57237-327-04 (4 suppositories in 1 blister pack)

Front Foil

Bisc-supp-02

Back Foil

Bisc-supp-03

BISACODYL 
bisacodyl suppository
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57237-327
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
ColorwhiteScore    
ShapeBULLETSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57237-327-213 in 1 CARTON08/24/2023
1NDC:57237-327-044 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:57237-327-036 in 1 CARTON08/24/2023
2NDC:57237-327-515 in 1 BLISTER PACK; 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 - Rising Pharma Holdings, Inc. (116880195)
Establishment
NameAddressID/FEIBusiness Operations
Bliss GVS Pharma Limited675630493manufacture(57237-327) , analysis(57237-327) , pack(57237-327)

Revised: 9/2023
Document Id: b43e0a3d-ffe6-42e0-83d1-5d9c2c46a86d
Set id: 03429da4-1ce9-4789-bf54-ce1b3215b013
Version: 1
Effective Time: 20230908
 
Rising Pharma Holdings, Inc.