PROCTOZONE-G- glycerin suppository

Proctozone-G by

Drug Labeling and Warnings

Proctozone-G 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)

Glycerin USP, 1.2 grams

PURPOSE

Purpose

Laxative

INDICATIONS & USAGE

Uses

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

WARNINGS

Warnings

For rectal use only

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

Ask a doctor before use if the child has

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

When using this product your child may have rectal discomfort or a burning sensation

Stop use and ask a doctor if you have

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

Keep out of reach of children

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

DOSAGE & ADMINISTRATION

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 help 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
• Children 2 to under 6 years of age ...................... 1 suppository once daily
• Children under 2 years ............................................ ask a doctor

STORAGE AND HANDLING

Other Information

Keep away from excessive heat.

INACTIVE INGREDIENT

Inactive ingredients

purified water, sodium stearate.

QUESTIONS

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

PRINCIPAL DISPLAY PANEL

NDC: 57237-338-21 (2 blisters of 6 suppositories)

Proctozone-GTM

GLYCERIN SUPPOSITORIES 1.2 g

RECTAL LAXATIVE

Front Foil (57237-338-16)

Back Foil (57237-338-16)

NDC: 57237-338-52 (5 blisters of 5 suppositories)

Front Foli (57237-338-51)

Back Foil (57237-338-51)

INGREDIENTS AND APPEARANCE

PROCTOZONE-G 
glycerin suppository

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57237-338
Route of Administration	RECTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	GLYCERIN	1.2 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SODIUM STEARATE (UNII: QU7E2XA9TG)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57237-338-21	2 in 1 CARTON	07/31/2025
1	NDC: 57237-338-16	6 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 57237-338-52	5 in 1 CARTON	07/31/2025
2	NDC: 57237-338-51	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	M007.54	07/31/2025

Labeler - Rising Pharma Holdings, Inc. (116880195)

Establishment
Name	Address	ID/FEI	Business Operations
Bliss GVS Pharma Limited		675630493	manufacture(57237-338) , analysis(57237-338) , pack(57237-338)