PROCTOZONE-B- bisacodyl suppository

Proctozone-B by

Drug Labeling and Warnings

Proctozone-B by is a Otc medication manufactured, distributed, or labeled by Rising Pharma Holdings, Inc., Bliss GVS Pharma Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredient (in each suppository) 

Bisacodyl USP, 10 mg

PURPOSE

Purpose

Stimulant Laxative

INDICATIONS & USAGE

Use

• for relief of occasional constipation (irregularity)
• this product generally produces bowel movement in 15 minutes to 1 hour

WARNINGS

Warnings

For rectal use only

ASK DOCTOR

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

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

STOP USE

Stop use and ask a doctor if

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

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask health professional before use.

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.

DOSAGE & ADMINISTRATION

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 years: 1/2 suppository in a single daily dose
• children under 6 years: Do not use

STORAGE AND HANDLING

Other information

• store at 20-25°C (68-77°F)
• if suppository softens prior to use, may be placed in refrigerator for short time

INACTIVE INGREDIENT

Inactive ingredient hard fat

QUESTIONS

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

OTHER SAFETY INFORMATION

TAMPER EVIDENT, INDIVIVIDUALLY SEALED FOR YOUR PROTECTION

SPL UNCLASSIFIED SECTION

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

Made in India

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

Issued: 09/2024

PRINCIPAL DISPLAY PANEL

NDC: 57237-337-21 (3 blisters of 4 suppositories)

Proctozone-BTM

Bisacodyl (USP) 10 mg Suppositories 

MEDICATED LAXATIVE SUPPOSITORY

Gentle, Predictable Relief

DO NOT SWALLOW

NDC: 57237-337-04 (4 suppositories in 1 blister pack)

Front Foil

NDC: 57237-337-04 (4 suppositories in 1 blister pack)

Back Foil

INGREDIENTS AND APPEARANCE

PROCTOZONE-B 
bisacodyl suppository

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57237-337
Route of Administration	RECTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BISACODYL (UNII: 10X0709Y6I) (DEACETYLBISACODYL - UNII:R09078E41Y)	BISACODYL	10 mg

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

Product Characteristics
Color	white	Score
Shape	BULLET	Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57237-337-21	3 in 1 CARTON	12/01/2024
1	NDC: 57237-337-04	4 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 57237-337-03	6 in 1 CARTON	02/01/2025
2	NDC: 57237-337-51	5 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M007	08/24/2023

Labeler - Rising Pharma Holdings, Inc. (116880195)

Establishment
Name	Address	ID/FEI	Business Operations
Bliss GVS Pharma Limited		675630493	manufacture(57237-337) , analysis(57237-337) , pack(57237-337)