Indications and uses
relieves occasional constipation (irregularity) generally produces bowel movement in 1/4 to 1 hour
Leader Glycerin
- Manufacturer
- Cardinal Health, 110 dba LEADER | Unipack, Inc.
- Effective date
- 2022-01-19
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 6
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 22:13:38
Label at a glance#
ProductLeader Glycerin Laxative
Active ingredientGLYCERIN
Label structure13 sections
Dosage and administration
adults and children 6 years and over 1 suppository per day or as directed by doctor children 2 to under 6 years use CVS/pharmacy(TM) Child Suppositories children under 2 years ask a doctor insert 1 suppository well up into the rectum and retain fo 15 minutes it need not melt to produce laxative action
Label contents#
Full prescribing information#
Active Ingredient
Active Ingredient Purpose
(in each suppository)
Glycerin, USP 2 grams ............................................Laxative
Uses
relieves occasional constipation (irregularity)
generally produces bowel movement in 1/4 to 1 hour
Warnings
For rectal use only
Do not use
Do not use laxative products for longer than 1 week unless directed by a doctor
Ask a doctor before use if you have
Ask a doctor before use if you have
- abdominal pain - nausea - vomiting - noticed a sudden change in bowel habits that lasts over 2 weeks
When using this product
When using this product you may have rectal discomfort or a burning sensation
Stop use and ask a doctor if
Stop use and ask a doctor if
-you have rectal bleeding
-you fail to have a bowel movement after use of a laxative
These could be signs of a serious condition.
If pregnant or breast-feeding,
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
adults and children 6 years and over 1 suppository per day or as directed by doctor
children 2 to under 6 years use CVS/pharmacy(TM) Child Suppositories
children under 2 years ask a doctor
insert 1 suppository well up into the rectum and retain fo 15 minutes
it need not melt to produce laxative action
Other information
keep tightly closed - avoid excessive heat
Inactive ingredients
purified water, sodium hydroxide, stearic acid
Product Label
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 70000-0450-1 | 2024-02-14 | C162847 | 48780-1 | 1030e365-232f-111a-e063-dadaa90a10e2 | Drug Facts |
| 70000-0450-1 | 2024-01-30 | C162847 | 48780-1 | 1030e365-232f-111a-e063-dadaa90a10e2 | Drug Facts |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 70000-0450-1 | EA - Each | 70000-0450 | 74e91550-6046-4fd3-bf2d-9215c8318782 | 1 | 2019-08-06 |
Products#
Every source-derived product name is available through these pages.
- Leader Glycerin Laxative
- Glycerin
- STEARIC ACID
- SODIUM HYDROXIDE
- WATER
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 70000-0450 | 70000-0450-1 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| STEARIC ACID | 4ELV7Z65AP | IACT |
| SODIUM HYDROXIDE | 55X04QC32I | IACT |
| WATER | 059QF0KO0R | IACT |
| GLYCERIN | PDC6A3C0OX | ACTIB |
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 115c5b3a-9907-5348-e063-6294a90af6bc | c76726b1-a162-41c7-9a6a-c69b0db6dc2b | 2024-02-14 | Warnings | c76726b1-a162-41c7-9a6a-c69b0db6dc2b |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.