Proctozone-gmaxtm

Drug Facts

Composition & Product

Active Ingredients

Glycerin (2 g)

Inactive Ingredients

Water Sodium Stearate

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2025-07-31

Medication Information

Warnings and Precautions

Warnings

For rectal use only

Indications and Usage

Uses

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

Dosage and 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 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

Description

Drug Facts

Section 42229-5

Drug Facts

Section 44425-7

Other Information

Keep away from excessive heat.

Section 50565-1

Keep out of reach of children

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

Section 50566-9

Stop use and ask a doctor if you have

Rectal bleeding
No bowel movement after using this product

These may indicate a serious condition.

Section 50567-7

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

Section 50569-3

Ask a doctor before use if you have

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

Section 50570-1

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

Section 51727-6

Inactive ingredients

purified water, sodium stearate.

Section 51945-4

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

Proctozone-GMax^TM

GLYCERIN SUPPOSITORIES 2 g

ADULT'S LAXATIVE

For Gentle, Predictable Relief of Occassional Constipation

Front Foil (57237-339-16)

Back Foil (57237-339-16)

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

Front Foil (57237-339-51)

Back Foil (57237-339-51)

Section 53413-1

Questions or Comments:

call 1-844-474-7464

Section 55105-1

Purpose

Laxative

Section 55106-9

Active ingredient (in each suppository)

Glycerin USP, 2 g

Structured Label Content

Indications and Usage (34067-9)

Uses

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

Dosage and Administration (34068-7)

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

Warnings and Precautions (34071-1)

Warnings

For rectal use only

Section 42229-5 (42229-5)

Drug Facts

Section 44425-7 (44425-7)

Other Information

Keep away from excessive heat.

Section 50565-1 (50565-1)

Keep out of reach of children

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

Section 50566-9 (50566-9)

Stop use and ask a doctor if you have

Rectal bleeding
No bowel movement after using this product

These may indicate a serious condition.

Section 50567-7 (50567-7)

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

Section 50569-3 (50569-3)

Ask a doctor before use if you have

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

Section 50570-1 (50570-1)

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

Section 51727-6 (51727-6)

Inactive ingredients

purified water, sodium stearate.

Section 51945-4 (51945-4)

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

Proctozone-GMax^TM

GLYCERIN SUPPOSITORIES 2 g

ADULT'S LAXATIVE

For Gentle, Predictable Relief of Occassional Constipation

Front Foil (57237-339-16)

Back Foil (57237-339-16)

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

Front Foil (57237-339-51)

Back Foil (57237-339-51)

Section 53413-1 (53413-1)

Questions or Comments:

call 1-844-474-7464

Section 55105-1 (55105-1)

Purpose

Laxative

Section 55106-9 (55106-9)

Active ingredient (in each suppository)

Glycerin USP, 2 g

Advanced Ingredient Data

[{"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM STEARATE", "unii": "QU7E2XA9TG", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "ACTIB", "strengthNumerator": "2", "strengthDenominator": "1", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "1"}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Uses For relief of occasional constipation This product usually produces bowel movement in 1/4 to 1 hour", "34068-7": "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", "34071-1": "Warnings For rectal use only", "42229-5": "Drug Facts", "44425-7": "Other Information Keep away from excessive heat.", "50565-1": "Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center right away.", "50566-9": "Stop use and ask a doctor if you have Rectal bleeding No bowel movement after using this product These may indicate a serious condition.", "50567-7": "When using this product it may cause rectal discomfort or a burning sensation", "50569-3": "Ask a doctor before use if you have Abdominal pain, nausea or vomiting A sudden change in bowel habits lasting more than 2 weeks", "50570-1": "Do not use for longer than 1 week unless directed by a doctor.", "51727-6": "Inactive ingredients purified water, sodium stearate.", "51945-4": "NDC 57237-339-21 (2 blisters of 6 suppositories) Proctozone-GMax TM GLYCERIN SUPPOSITORIES 2 g ADULT'S LAXATIVE For Gentle, Predictable Relief of Occassional Constipation Front Foil (57237-339-16) Back Foil (57237-339-16) NDC 57237-339-52 (5 blisters of 5 suppositories) Front Foil (57237-339-51) Back Foil (57237-339-51)", "53413-1": "Questions or Comments: call 1-844-474-7464", "55105-1": "Purpose Laxative", "55106-9": "Active ingredient (in each suppository) Glycerin USP, 2 g"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information