Proctozone-G
Proctozone-G Glycerin Suppositories 1.2 g
8a5c8ad5-3619-4971-967d-165270a20bc8
HUMAN OTC DRUG LABEL
Jun 12, 2025
Rising Pharma Holdings, Inc.
DUNS: 116880195
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Glycerin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (3)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 57237-338-21 (2 blisters of 6 suppositories)
Proctozone-G****TM
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)
F****ront Foli (57237-338-51)
B****ack Foil (57237-338-51)
INDICATIONS & USAGE SECTION
Uses
- For relief of occasional constipation
- This product usually produces bowel movement in 1/4 to 1 hour
OTC - ACTIVE INGREDIENT SECTION
Active ingredient (in each suppository)
Glycerin USP, 1.2 grams
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
OTC - QUESTIONS SECTION
Questions or Comments:
call 1-844-474-7464
OTC - PURPOSE SECTION
Purpose
Laxative
WARNINGS SECTION
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.
STORAGE AND HANDLING SECTION
Other Information
Keep away from excessive heat.
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 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
INACTIVE INGREDIENT SECTION
** Inactive ingredients**
purified water, sodium stearate.