FDA label 8f0fc39b-9919-6bc4-e053-2a95a90a384f

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
8f0f416f-b5b9-d856-e053-2a95a90a23dc
SPL ID
8f0fc39b-9919-6bc4-e053-2a95a90a384f
Version
1
Effective date
2019-08-01
Source export date
2026-09-28
Source partition
6
Source file
https://download.open.fda.gov/drug/label/drug-label-0006-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/e0861bcde1444ef952820955caafc6f3fd29783e5ade07a13d933aa3336b399f/drug-label-0006-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:43:09

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 For external use only ; avoid contact with eyes. Do not use • by mouth • in nostrils • on wounds or damaged skin • with tight bandages Ask a doctor before use if you have • cough that occurs with too much phlegm (mucus) • persistent or chronic cough such as occurs with smoking, asthma or emphysema When using this product do not • heat • microwave • add to hot water or any container where heating water. May cause splattering and result in burns. Stop use and ask a doctor if • muscle aches and pains worsen or persist for more than 7 days or clear up and occur again within a few days. • cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Reported adverse events (FAERS/openFDA)#

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