drug facts

drug facts

SPL v1

SPL

SPL Set ID 8baae8b1-e9ce-4247-b364-f94407322788

Route

rectal

Published

Effective Date 2010-02-04

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

glycerin (1.3 g)

Inactive Ingredients

sodium stearate water

Identifiers & Packaging

Marketing Status

otc monograph final active Since 2005-09-09

Purpose

Laxative

Description

Glycerin, USP 80.7%

Medication Information

Warnings and Precautions

Warnings

For rectal use only. May cause rectal discomfort or a burning sensation.

Purpose

Laxative

Directions

Children 2 - 6 years of age: carefully insert one suppository well into the rectum
Do not use more than once per day
Generally produces a bowel movement in 15 minutes to 1 hour
Children under 2 years of age: ask a doctor.

Other Information

Store container tightly closed
Store at room temperature: 15°- 30° C (59° - 86° F). Do not exceed 30° C (86° F).

Inactive Ingredients

sodium stearate, purified water

Description

Glycerin, USP 80.7%

Use

For relief of occasional constipation

Section 42229-5

Section 50567-7

Section 50568-5

Section 53413-1

Section 53414-9

Do Not Use

more than one per day
for a period of longer than one week unless directed by a doctor
laxative products when abdominal pain, nausea, or vomiting are present unless directed by a doctor
if seal under product lid is damaged, missing or broken.

Ask A Doctor

before use if you have noticed a sudden change in bowel habits that persists over a period of two weeks
if you are pregnant or nursing a baby

Package Label

Sunmark®

COMPARE TO FLEET® ACTIVE INGREDIENT*

NDC 49348-158-05

Laxative

Suppositories

Glycerin

For fast, gentle relief of occasional constipation

PEDIATRIC

25 SUPPOSITORIES

Another Quality Product

Distributed by McKesson

One Post Street, San

Francisco, CA 94104

Money Back Guarantee

Please visit us at

www.sunmarkbrand.com

*This product is not manufactured or distributed by C.B.Fleet co., owner of

the registered trademark Fleet®.

USE ONLY IF PRINTED

INNER SEAL IS NOT BROKEN

OR MISSING

Active Ingredient

Glycerin, USP 80.7%

Stop Use and Ask A Doctor

if you have rectal bleeding or fail to have a bowel movement after using a laxative. This may indicate a serious condition.

Keep Out of Reach of Children

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

Structured Label Content

Warnings and Precautions (34071-1)

Warnings (WARNINGS)

For rectal use only. May cause rectal discomfort or a burning sensation.

Purpose (PURPOSE)

Laxative

Directions (DIRECTIONS)

Children 2 - 6 years of age: carefully insert one suppository well into the rectum
Do not use more than once per day
Generally produces a bowel movement in 15 minutes to 1 hour
Children under 2 years of age: ask a doctor.

Other Information (OTHER INFORMATION)

Store container tightly closed
Store at room temperature: 15°- 30° C (59° - 86° F). Do not exceed 30° C (86° F).

Inactive Ingredients (INACTIVE INGREDIENTS)

sodium stearate, purified water

Use (USE)

For relief of occasional constipation

Section 42229-5 (42229-5)

Section 50567-7 (50567-7)

Section 50568-5 (50568-5)

Section 53413-1 (53413-1)

Section 53414-9 (53414-9)

Do Not Use (Do not use)

more than one per day
for a period of longer than one week unless directed by a doctor
laxative products when abdominal pain, nausea, or vomiting are present unless directed by a doctor
if seal under product lid is damaged, missing or broken.

Ask A Doctor (Ask a doctor)

before use if you have noticed a sudden change in bowel habits that persists over a period of two weeks
if you are pregnant or nursing a baby

Package Label (PACKAGE LABEL)

Active Ingredient (ACTIVE INGREDIENT)

Glycerin, USP 80.7%

Stop Use and Ask A Doctor (Stop use and ask a doctor)

if you have rectal bleeding or fail to have a bowel movement after using a laxative. This may indicate a serious condition.

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.

Advanced Ingredient Data

[{"name": "glycerin", "unii": "PDC6A3C0OX", "classCode": "ACTIB", "strengthNumerator": "1.3", "strengthDenominator": "1", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "1"}, {"name": "sodium stearate", "unii": "QU7E2XA9TG", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "water", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"USE": "For relief of occasional constipation", "PURPOSE": "Laxative", "WARNINGS": "For rectal use only. May cause rectal discomfort or a burning sensation.", "DIRECTIONS": "Children 2 - 6 years of age: carefully insert one suppository well into the rectum Do not use more than once per day Generally produces a bowel movement in 15 minutes to 1 hour Children under 2 years of age: ask a doctor.", "Do not use": "more than one per day for a period of longer than one week unless directed by a doctor laxative products when abdominal pain, nausea, or vomiting are present unless directed by a doctor if seal under product lid is damaged, missing or broken.", "Ask a doctor": "before use if you have noticed a sudden change in bowel habits that persists over a period of two weeks if you are pregnant or nursing a baby", "PACKAGE LABEL": "Sunmark® COMPARE TO FLEET® ACTIVE INGREDIENT* NDC 49348-158-05 Laxative Suppositories Glycerin For fast, gentle relief of occasional constipation PEDIATRIC 25 SUPPOSITORIES Another Quality Product Distributed by McKesson One Post Street, San Francisco, CA 94104 Money Back Guarantee Please visit us at www.sunmarkbrand.com *This product is not manufactured or distributed by C.B.Fleet co., owner of the registered trademark Fleet®. USE ONLY IF PRINTED INNER SEAL IS NOT BROKEN OR MISSING", "ACTIVE INGREDIENT": "Glycerin, USP 80.7%", "OTHER INFORMATION": "Store container tightly closed Store at room temperature: 15°- 30° C (59° - 86° F). Do not exceed 30° C (86° F).", "INACTIVE INGREDIENTS": "sodium stearate, purified water", "Stop use and ask a doctor": "if you have rectal bleeding or fail to have a bowel movement after using a laxative. This may indicate a serious condition.", "Keep out of reach of children": "If swallowed, get medical help or contact a Poison Control Center right away."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:00.125885 · Updated: 2026-03-14T22:52:17.029964