FDA label 678f8492-d4f8-0d54-e053-2a91aa0aebe6

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: b4cb6223-8d63-4208-acc9-79c1c8c9279e
SPL ID: 678f8492-d4f8-0d54-e053-2a91aa0aebe6
Version: 2
Effective date: 2018-03-16
Source export date: 2026-09-28
Source partition: 2
Source file: https://download.open.fda.gov/drug/label/drug-label-0002-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/f7d2b6e3f8600cd856280ab55a9c6fa54a642647191d164f9d1110e89f3f4097/drug-label-0002-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:16:40

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		678f8492-d4f8-0d54-e053-2a91aa0aebe6	id
spl set id		b4cb6223-8d63-4208-acc9-79c1c8c9279e	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 exceed recommended dosage because at higher dosages nervousness, dizziness, or sleeplessness may occur. Do not give the product for more than 5 days. If symptoms persist, or if new ones occur consult a doctor. If fever persists for more than 3 days (72 hours), or recurs, consult a doctor. Drink water with each dose Do not give this product at least after 7 days after a tonsillectomy or oral surgery, unless directed by a doctor. May cause drowsiness Do not give to children who have asthma or glaucoma, unless directed by a doctor. Do not give this product to children who have heart disease, high blood pressure, thyroid disease or diabetes, unless directed by a doctor.

Reported adverse events (FAERS/openFDA)#

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