FDA label ddef60bb-1138-46e5-9865-5f681bf88aeb

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
85d1dc2b-f349-4b8a-bfeb-32126d54d073
SPL ID
ddef60bb-1138-46e5-9865-5f681bf88aeb
Version
2
Effective date
2015-08-17
Source export date
2026-09-28
Source partition
13
Source file
https://download.open.fda.gov/drug/label/drug-label-0013-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/e78bf8aa9f90ab13e640d254dfbd4fe5bfeca4995ec5f9d51bce3356e249cab7/drug-label-0013-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 06:33:27

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 as 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 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. 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.