FDA.reportPublic FDA data

Glycerin Laxative

Manufacturer
Neilmed Pharmaceuticals Inc.
Effective date
2025-06-20
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:03:34

Label at a glance#

ProductGlycerin Laxative
Active ingredientGLYCERIN
Label structure16 sections

Indications and uses

• Relieves occasional constipation (irregularity) • Generally produces bowel movement in 15 minutes to 1 hour

Dosage and administration

Adults and children 6 years of age and over 1 suppository per day or as directed by a doctor. Children 2 to under 6 years Use Neilmed Child Suppositories Children under 2 years Ask a doctor Insert 1 suppository well into the rectum. To produce laxative action, suppository is designed to dissolve only partially and may not be noticeable.

Storage and handling

Store at room temperature. Do not exceed 30˚ C (86˚ F) Lot No. & Exp. Date: see wrapper or box

Label contents#

Full prescribing information#

Drug Facts: Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each suppository)
Glycerin, USP 2 grams

Drug Facts

OTC - PURPOSE SECTION

Active ingredient (in each suppository) ...............Purpose
Glycerin, USP 2 grams ...................................... Laxative

Uses

INDICATIONS & USAGE SECTION

• Relieves occasional constipation (irregularity)
• Generally produces bowel movement in 15 minutes to 1 hour

Warnings

WARNINGS SECTION

For rectal use only

Do not use

OTC - DO NOT USE SECTION

laxative products for longer than 1 week unless directed by a doctor

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

• Abdominal pain • Nausea • Vomiting • Noticed a sudden change in bowel habits that lasts over 2 weeks

When using the product

OTC - WHEN USING SECTION

you may have rectal discomfort or a burning sensation.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • You have rectal bleeding
  • You fail to have a bowel movement after use of a laxative. These could be a signs of a serious condition.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 6 years of age and over1 suppository per day or as directed by a doctor.
Children 2 to under 6 yearsUse Neilmed Child Suppositories
Children under 2 yearsAsk a doctor

Insert 1 suppository well into the rectum. To produce laxative action, suppository is designed to dissolve only partially and may not be noticeable.

Other Information

STORAGE AND HANDLING SECTION

  • Store at room temperature. Do not exceed 30˚ C (86˚ F)
  • Lot No. & Exp. Date: see wrapper or box

Inactive ingredients

INACTIVE INGREDIENT SECTION

Purified water, sodium hydroxide, stearic acid

Questions?

OTC - QUESTIONS SECTION

Questions or comments? 1 (877) 477-8633

Important:

SAFE HANDLING WARNING SECTION

Please do not discard this printed box and any enclosed printed material. The inside final product may not have all the details you require for the ongoing use of the product.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Glycerin 120ctGlycerin 120ctGlycerin 60ctGlycerin 60ctGlycerinGlycerin

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
13709-329-01Glycerin Laxative2.5 g in 1 BLISTER PACKSUPPOSITORY2.52
13709-329-01Glycerin Laxative30 in 1 CARTONSUPPOSITORY302
13709-329-02Glycerin Laxative2.5 g in 1 BLISTER PACKSUPPOSITORY2.52
13709-329-02Glycerin Laxative60 in 1 CARTONSUPPOSITORY602
13709-329-03Glycerin Laxative120 in 1 CARTONSUPPOSITORY1202
13709-329-03Glycerin Laxative2.5 g in 1 BLISTER PACKSUPPOSITORY2.52

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
13709-32913709-329-01, 13709-329-02, 13709-329-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXACTIB
STEARIC ACID4ELV7Z65APIACT
SODIUM HYDROXIDE55X04QC32IIACT
WATER059QF0KO0RIACT

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
Glycerin LaxativeGLYCERIN LAXATIVE SUPPOSITORIESNeilmed Pharmaceuticals Inc.35cc266a-196f-16ce-e063-6394a90a24af2025-06-20WarningsExact identifier
ndc (package): 13709-329-03
ndc (package): 13709-329-01
ndc (package): 13709-329-02
ndc (product): 13709-329
ndc11 (package): 13709032902
ndc11 (package): 13709032901
ndc11 (package): 13709032903
spl id: 3804f1ae-572a-9f6b-e063-6394a90a709b
spl set id: 35cc266a-196f-16ce-e063-6394a90a24af

Reported adverse events (FAERS/openFDA)#

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