FDA.reportPublic FDA data

Glycerin

Manufacturer
MAJOR® PHARMACEUTICALS
Effective date
2024-07-03
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 20:59:37

Label at a glance#

ProductGlycerin
Active ingredientGLYCERIN
Label structure11 sections

Indications and uses

For relief of occasional constipation. This product usually produces a bowel movement in ¼ to 1 hour.

Dosage and administration

Single Daily dosage: 1 suppository or as directed by a doctor  Adults and children 6 years and over tear wrapper prior to immediate use remove the secondary wrapper before inserting into the rectum as follows:    - hold suppository with pointed end up - carefully separate tabs with fingernail - gently pull apart by pulling tabs down on both sides    - remove suppository from wrapper    - insert one suppository wel...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

(in each suppository)

Glycerin, USP 2 g

Purpose

OTC - PURPOSE SECTION

Hyperosmotic laxative

Uses

INDICATIONS & USAGE SECTION

For relief of occasional constipation. This product usually produces a bowel movement in ¼ to 1 hour.

Warnings

WARNINGS SECTION

For rectal use only.

Do not use

OTC - DO NOT USE SECTION

laxative products when abdominal pain, nausea or vomiting are present unless directed by a doctor

Ask a doctor before use if

OTC - ASK DOCTOR SECTION

  • you have a sudden change in bowel habits lasting more than 2 weeks.
  • already used a laxative for more than 1 week.

When using this product

OTC - WHEN USING SECTION

rectal discomfort or burning sensation may occur

Stop using this product and consult a doctor if you have

OTC - STOP USE SECTION

  • rectal bleeding
  • no bowel movement within 1 hour of using this product

This may indicate a serious condition.

If pregnant or breastfeeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a doctor 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 (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Single Daily dosage: 1 suppository or as directed by a doctor

 Adults and children 6 years and over

  • tear wrapper prior to immediate use
  • remove the secondary wrapper before inserting into the rectum as follows:

   - hold suppository with pointed end up
- carefully separate tabs with fingernail
- gently pull apart by pulling tabs down on both sides
   - remove suppository from wrapper
   - insert one suppository well up into the rectum

  • Children 2 to 6 years use Children's Glycerin Suppositories
  • Children under 2 years of age: ask a doctor

Other information

OTHER SAFETY INFORMATION

• Only remove overwrap prior to immediate use

• Keep from excessive heat

• Do not use if overwrap is torn

Inactive ingredients

INACTIVE INGREDIENT SECTION

polyethylene glycol 400, sodium stearate

Questions?

OTC - QUESTIONS SECTION

(855) 879-4368

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MAJOR®

Glycerin
Suppositories

2 g

Laxative 

For fast, gentle reflief of occasional constipation

Unit Dose

25 Individually Wrapped Adult Suppositories

PDP Major Glycerin Adult CartonPDP Major Glycerin Adult Carton

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MAJOR®

Glycerin
Suppositories

2 g

Laxative

For fast, gentle reflief of occasional constipation

DO NOT OPEN UNTIL IMMEDIATE USE 

1 Individually Wrapped Adult Suppository

image descriptionimage description

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-7333GLYCERIN (GLYCERIN SUPPOSITORY) SUPPOSITORY [MAJOR® PHARMACEUTICALS]1Unmatched20240705_0dfdaed5-12cb-4bbf-a3cb-1fc1f1660b27.zip

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0904-73330904-7333-01, 0904-7333-17

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
POLYETHYLENE GLYCOL 400B697894SGQIACT
SODIUM STEARATEQU7E2XA9TGIACT
GLYCERINPDC6A3C0OXACTIB

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
5d8d78f1-f98b-40b9-8c42-f35155d2b8a60dfdaed5-12cb-4bbf-a3cb-1fc1f1660b272025-09-17WarningsExact identifier
spl set id: 0dfdaed5-12cb-4bbf-a3cb-1fc1f1660b27

Reported adverse events (FAERS/openFDA)#

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