FDA label a097c60c-0b46-427e-8a85-4139e3bbc5a1

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
b53319ce-ed4d-43a8-b118-944d2a6d8e5d
SPL ID
a097c60c-0b46-427e-8a85-4139e3bbc5a1
Version
3
Effective date
2018-10-23
Source export date
2026-10-12
Source partition
9
Source file
https://download.open.fda.gov/drug/label/drug-label-0009-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/fb14b8f3d34b45230a84f851c029385f512adf3f002423a9b78d4f7ca626ecec/drug-label-0009-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:21:58

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 Ask a doctor before use if you have • cough that occurs with too much phlegm (mucus) • chronic cough that lasts or occurs with smoking, asthma, or emphysema When using this product • do not heat • do not microwave • do not add to hot water or any container where heating water. May cause splattering and result in burns. • do not take by mouth or place in nostrils • do not get into eyes • do not apply to wounds or damaged skin • do not bandage tightly Stop use and ask a doctor if • cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache that lasts. These could be signs of a serious condition. • muscle aches and pains worsen, persist for more than 7 days, or clear up and occur again within a few days Keep out of 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.