FDA label eea18052-6aa1-d9cb-e053-2a95a90a047b

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
45eb3326-1310-4044-997c-42c4abc6789d
SPL ID
eea18052-6aa1-d9cb-e053-2a95a90a047b
Version
3
Effective date
2022-11-29
Source export date
2026-09-28
Source partition
5
Source file
https://download.open.fda.gov/drug/label/drug-label-0005-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/9839785a692b692224cd5f90f9e3a9514c9923a6f521ab83eed3bedc7c0e1d05/drug-label-0005-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:28:18

Warnings cross-check#

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

Warnings sections page 1 of 1 · 2 matching rows.

warnings

Warnings As with any drug ask a doctor before use if pregnant or breast-feeding. Consult a physician if: Symptoms persist for more than 7 days or worsen Inflammation, fever or infection develops Symptoms are accompanied by high fever (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 Poison Control Center immediately. Do not use this product for persistent or chronic cough such as asthma, smoking, 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. Do not use if preprinted tamper band is broken or missing. In case of emergency, contact a medical professional or Poison Control Center immediately. Hyland's may also be contacted for emergency information about our products 24 hours a day, 7 days per week at (800) 624-9659.

warnings

Warnings Consult a physician if: Symptoms persist for more than 7 days or worsen Inflammation, fever or infection develops Symptoms are accompanied by high fever (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 Poison Control Center immediately. Do not use this product for persistent or chronic cough such as asthma, smoking, 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. Do not use if preprinted tamper band is broken or missing. In case of emergency, contact a medical professional or Poison Control Center immediately. Hyland's may also be contacted for emergency information about our products 24 hours a day, 7 days per week at (800) 624-9659.

Reported adverse events (FAERS/openFDA)#

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