FDA label 2e638aa7-d40d-4103-a097-9ec00cd203a7

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)

SPL set ID
ec28b5e0-2b8b-4cb9-a2dc-4ce6e4e3cdfd
SPL ID
2e638aa7-d40d-4103-a097-9ec00cd203a7
Version
3
Effective date
2016-01-14
Source export date
2026-08-01
Source partition
12
Source file
https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-08-01/d245bd7ce31d1d8ed63276109973402ece6c44860774da30f25b731cd7418983/drug-label-0012-of-0014.json.zip
Source manifest SHA-256
bdd1454d0606b622b70458a306b8a10d8a8787db06fd9f46e69c7f7a4524b630
Import run
20260801T225920Z
Imported at
2026-08-01 23:35:42

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 Do not use in children under 6 years of age in persons who cannot swallow without chewing Ask a doctor before use if you have abdominal pain nausea vomiting sudden change in bowel movements that persists over a period of 2 weeks When using this product do not use for a period longer than 1 week unless directed by a doctor you may experience abdominal discomfort, faintness and cramps Stop use and ask a doctor if rectal bleeding occurs you fail to have a bowel movement If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.