FDA label 0812acaf-b409-9b85-e063-6294a90a39e7

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
5d0320c8-f764-7be4-e053-2a91aa0a1466
SPL ID
0812acaf-b409-9b85-e063-6294a90a39e7
Version
3
Effective date
2023-10-19
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 05:16:06

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

Stop use and ask a doctor if:  • symptoms persist for more than 7 days or worsen • cough persists for more than 7 days, tends to recur, or is accompanied by a rash, persistent headache, fever that lasts for more than three days or if new symptoms occur Do not take this product For persistent or chronic cough such as occurs with smoking, asthma or emphysema, or if cough is accompanied by excessive phlegm (mucus) unless directed by a doctor. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center immediately. In case of emergency In case of emergency, contact a medical professional or Poison Control Center immediately.

Reported adverse events (FAERS/openFDA)#

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