FDA.reportPublic FDA data

Proctozone GMax

Manufacturer
Rising Pharma Holdings, Inc. | Bliss GVS Pharma Limited
Effective date
2026-01-06
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:33:18

Label at a glance#

ProductProctozone GMax
Active ingredientGLYCERIN
Label structure12 sections

Storage and handling

Other Information Keep away from excessive heat.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each suppository)

Glycerin USP, 2 g

OTC - PURPOSE SECTION

Purpose

Laxative

INDICATIONS & USAGE SECTION

Uses

  • For relief of occasional constipation
  • This product usually produces bowel movement in 1/4 to 1 hour

WARNINGS SECTION

Warnings

For rectal use only

OTC - DO NOT USE SECTION

Do not use for longer than 1 week unless directed by a doctor.

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

  • Abdominal pain, nausea or vomiting
  • A sudden change in bowel habits lasting more than 2 weeks

OTC - WHEN USING SECTION

When using this product it may cause rectal discomfort or a burning sensation

OTC - STOP USE SECTION

Stop use and ask a doctor if you have

  • Rectal bleeding
  • No bowel movement after using this product
    These may indicate a serious condition.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Directions

  • Tear off one suppository from the strip
  • If the suppository seems soft, place it in the refrigerator before use or run cold water over it before removing the foil wrapper
  • Gently remove suppository by peeling apart the wrapper (see illustration 1)
  • Rub a water-based lubricant over the tip or dip it in water. It will hep you slide it in smoothly
  • Lie on your side and insert 1 suppository, tapered end first, about the length of your finger into the rectum (see illustration 2)
  • Hold the suppository for about 15-20 minutes to allow time for it to melt
  • Adults and children 6 years of age and over...................... 1 suppository once daily
  • Children under 6 years age............................................ do not use

STORAGE AND HANDLING SECTION

Other Information

Keep away from excessive heat.

INACTIVE INGREDIENT SECTION

Inactive ingredients

purified water, sodium stearate.

OTC - QUESTIONS SECTION

Questions or Comments:

call 1-844-474-7464

SPL UNCLASSIFIED SECTION

TAMPER EVIDENT, INDIVIDUALLY 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: 05/2025

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 57237-339-21 (2 blisters of 6 suppositories)

Proctozone-GMaxTM

GLYCERIN SUPPOSITORIES 2 g

ADULT'S LAXATIVE

For Gentle, Predictable Relief of Occassional Constipation

57237-339-21- proctozone-Gmax fig-0157237-339-21- proctozone-Gmax fig-01

57237-339-21- proctozone G-max fig-0257237-339-21- proctozone G-max fig-02

Front Foil (57237-339-16)

12005010 proctozone G max front foil12005010 proctozone G max front foil

Back Foil (57237-339-16)

12005013 back foil12005013 back foil

NDC 57237-339-52 (5 blisters of 5 suppositories)

proctozone G max-1 carton labelproctozone G max-1 carton label

proctozone G max carton label-52proctozone G max carton label-52

Front Foil (57237-339-51)

proctozone Gmax front foilproctozone Gmax front foil

Back Foil (57237-339-51)

proctozone Gmax back foilproctozone Gmax back foil

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
104155glycerin 2 GM Rectal SuppositoryPSN2
104155glycerin 2000 MG Rectal SuppositorySCD2
104155glycerin 2 GM Rectal SuppositorySY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
GLYCERIN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57237-339-16Proctozone GMax6 in 1 BLISTER PACKSUPPOSITORY62
57237-339-21Proctozone GMax2 in 1 CARTONSUPPOSITORY22
57237-339-51Proctozone GMax5 in 1 BLISTER PACKSUPPOSITORY52
57237-339-52Proctozone GMax5 in 1 CARTONSUPPOSITORY52

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57237-339-16EA - Each57237-3398d94a140-015d-44f7-8f75-13551bd8576512026-04-20
57237-339-21EA - Each57237-3390d4a94b4-790e-4bda-957a-49d320c74e0b12025-11-13
57237-339-51EA - Each57237-33978bf1995-d145-48c5-8630-6dac1b54d64a12026-04-20
57237-339-52EA - Each57237-3396fd65dad-1070-43dc-8422-2c401a7d3e5f12026-03-17

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
57237-33957237-339-16, 57237-339-21, 57237-339-51, 57237-339-52

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
SODIUM STEARATEQU7E2XA9TGIACT
GLYCERINPDC6A3C0OXACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Proctozone GMaxGLYCERINRising Pharma Holdings, Inc.a13c2be6-d650-4b53-bddd-d55e92fe10c62026-01-06WarningsExact identifier
ndc (package): 57237-339-21
ndc (package): 57237-339-16
ndc (package): 57237-339-52
ndc (package): 57237-339-51
ndc (product): 57237-339
ndc11 (package): 57237033921
ndc11 (package): 57237033951
ndc11 (package): 57237033952
ndc11 (package): 57237033916
spl id: 8e27aa33-f09a-42d8-8cfe-efe6ca44f9b4
spl set id: a13c2be6-d650-4b53-bddd-d55e92fe10c6

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.