FDA label 7c4cb251-0c78-44cf-e053-2a91aa0a99ae

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: a34d53d5-01c2-4b44-a720-510b1ab6246f
SPL ID: 7c4cb251-0c78-44cf-e053-2a91aa0a99ae
Version: 2
Effective date: 2018-12-05
Source export date: 2026-09-28
Source partition: 11
Source file: https://download.open.fda.gov/drug/label/drug-label-0011-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/aa96b5a2be6b394393acd0090f6948bdf99e0e8e00666f81608929c8fa83db77/drug-label-0011-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 06:20:42

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 · 2 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
spl id		7c4cb251-0c78-44cf-e053-2a91aa0a99ae	id
spl set id		a34d53d5-01c2-4b44-a720-510b1ab6246f	set_id

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 Unsuitable for children, pregnant women, lactating women Storage and Shelf Life 24 months. Tightly closed and store in a dry place Directions 1 caplet, one or two times daily Pregnancy or Breast Feeding Unsuitable for pregnant or lactating women Keep Out of Reach of Children Unsuitable for children

Reported adverse events (FAERS/openFDA)#

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