FDA label 78e7869b-2b28-480e-e053-2991aa0acd4b

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: 0bddba0a-eade-47da-8373-fcb10d723b62
SPL ID: 78e7869b-2b28-480e-e053-2991aa0acd4b
Version: 2
Effective date: 2018-10-23
Source export date: 2026-09-28
Source partition: 7
Source file: https://download.open.fda.gov/drug/label/drug-label-0007-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/bb1af06e95bcf9567b07e56fcf3a03c0cac3c7c82ff89d4c970881174949e5b7/drug-label-0007-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:49:59

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		78e7869b-2b28-480e-e053-2991aa0acd4b	id
spl set id		0bddba0a-eade-47da-8373-fcb10d723b62	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 Do not use more than 15 tablets in a 24 hour period or use the maximum dosage for more than 2 weeks except under the advice and supervision of a doctor Ask Doctor or Pharmacist before use if you are If Pregnancy or Breast Feeding ask a health professional before use Keep Out of Reach of Children [Enter Keep Out of Reach of Children here]

Reported adverse events (FAERS/openFDA)#

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