Stratuscare Glycerin Laxative Pediatric

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

Brand name: Stratuscare Glycerin Laxative Pediatric
Generic name: GLYCERIN
Manufacturer: Stratus Pharmaceuticals
Product type: HUMAN OTC DRUG
SPL set ID: 6ae6d3c4-bb3b-4436-b76d-8654bf871e66
SPL ID: 4c627848-1463-4afc-bfd6-e310b1ef0ffa
Version: 4
Effective date: 2024-11-01
Source export date: 2026-10-27
Source partition: 9
Source file: https://download.open.fda.gov/drug/label/drug-label-0009-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-27/a73bb3b6a943796a18cd4bcd0917240b579be4636d00e6e39481bafbd8093f69/drug-label-0009-of-0014.json.zip
Source manifest SHA-256: 6be3667a3beefe6c0ead4c723ea963050533a2bc725a8044d58b07d18b258c55
Import run: 20261027T193451Z
Imported at: 2026-10-27 20:34:54

Harmonized routes table
Harmonized routes
RECTAL

Harmonized identifier links#

Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.

Harmonized identifiers page 1 of 1 · 13 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M007	openfda.application_number
brand name		Stratuscare Glycerin Laxative Pediatric	openfda.brand_name
generic name		GLYCERIN	openfda.generic_name
manufacturer name		Stratus Pharmaceuticals	openfda.manufacturer_name
ndc	package	58980-409-12	openfda.package_ndc
ndc	package	58980-409-25	openfda.package_ndc
ndc	product	58980-409	openfda.product_ndc
ndc11	package	58980040912	derived:openfda.package_ndc
ndc11	package	58980040925	derived:openfda.package_ndc
rxcui		252062	openfda.rxcui
spl id		4c627848-1463-4afc-bfd6-e310b1ef0ffa	id
spl set id		6ae6d3c4-bb3b-4436-b76d-8654bf871e66	set_id
unii		PDC6A3C0OX	openfda.unii

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 1 matching rows.

warnings

Warnings For rectal use only. May cause rectal discomfort or burning sensation. Ask a doctor before use if your child has: abdominal pain, nausea or vomiting a sudden change in bowel habits lasting more than 2 weeks. Stop use and ask a doctor: if your child has rectal bleeding or fails to have a bowel movement after using a laxative. This may indicate a serious condition. Do not use laxative products for longer than 1 week unless directed by a doctor Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center immediately (1-800-222-1212).

Reported adverse events (FAERS/openFDA)#

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