FDA label 4a1bc8bc-e476-48c5-b8d4-0bd1bae63970

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
75ad8ebf-c8f2-4f9b-802b-fe63fc985ede
SPL ID
4a1bc8bc-e476-48c5-b8d4-0bd1bae63970
Version
2
Effective date
2024-12-27
Source export date
2026-09-28
Source partition
8
Source file
https://download.open.fda.gov/drug/label/drug-label-0008-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/ae3816359e336a5de4f44607730a3d12ceb61ffa012a132189ceda22541b38ee/drug-label-0008-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:54:52

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 4 matching rows.

warnings

Warnings As with any drug, ask a doctor before use if pregnant or breast-feeding. Keep this and all medications out of the reach of children. In case of accidental overdose, contact a medical professional or a poison control center immediately. Consult a physician if: symptoms persistent for more than 7 days or worsen inflammation, fever or infection develops symptoms are accompanied by high fever (over 101° F) cough tends to recur or is accompanied by high fever, rash or persistent headache Do not use this product for persistent or chronic cough such as asthma, smoking or emphysema or if cough is accompanied by excessive phlegm (mucus), unless directed by a licensed medical professional. A persistent cough may be a sign of a serious condition. Sore throat warning: Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea and vomiting may be serious. Consult a doctor promptly. In case of emergency, contact a medical professional or Poison Control Center immediately.

warnings

A persistent cough may be a sign of a serious condition. Sore throat warning: Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea and vomiting may be serious. Consult a doctor promptly. In case of emergency, contact a medical professional or Poison Control Center immediately.

warnings

Warnings As with any drug, ask a doctor before use if pregnant or breast-feeding. Consult a physician if: symptoms persistent for more than 7 days or worsen inflammation, fever or infection develops symptoms are accompanied by high fever (over 101° F) cough tends to recur or is accompanied by high fever, rash or persistent headache Keep this and all medications out of the reach of children. In case of accidental overdose, contact a medical professional or a poison control center immediately. Do not use this product for persistent or chronic cough such as asthma, smoking or emphysema or if cough is accompanied by excessive mucus, unless directed by a licensed health care professional. A persistent cough may be a sign of a serious condition. Sore throat warning: Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea and vomiting may be serious. Consult a doctor promptly. In case of emergency, contact a medical professional or Poison Control Center immediately.

warnings

A persistent cough may be a sign of a serious condition. Sore throat warning: Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea and vomiting may be serious. Consult a doctor promptly. 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.