FDA label db528c33-6c2b-4265-9baf-1cb5fe2a0078

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: f09776f9-50bf-48cc-bcfd-8807324d8fc1
SPL ID: db528c33-6c2b-4265-9baf-1cb5fe2a0078
Version: 2
Effective date: 2024-11-01
Source export date: 2026-10-12
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/2026-10-12/a497e765d824a2e2aa9e88d5f0eea2aae9dcba363989e5f163395cda5c3c9dd8/drug-label-0011-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 02:46:37

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		db528c33-6c2b-4265-9baf-1cb5fe2a0078	id
spl set id		f09776f9-50bf-48cc-bcfd-8807324d8fc1	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: In case of overdose, get medical help or contact a Poison Control Center right away. Do not take this product for headache pain for more than 10 days (for adults) or 5 days (for children) unless directed by a physician. If pain persists or gets worse or if new symptoms occur, consult a physician, because these could be signs of a serious condition. As with any medicine, if you are pregnant, may become pregnant, or breastfeeding, or taking prescription medications, seek the advice of a health care professional before using this product. Keep this and all medicines out of the reach of children. Tamper Evident: Do not use if foil blister backing is broken. Foil backing is printed with product name and lot number.

Reported adverse events (FAERS/openFDA)#

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