FDA label 46510730-05f9-13bb-e063-6394a90af207

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
7276d1cd-faba-3d21-e053-2a91aa0a5f9a
SPL ID
46510730-05f9-13bb-e063-6394a90af207
Version
5
Effective date
2025-12-19
Source export date
2026-10-12
Source partition
6
Source file
https://download.open.fda.gov/drug/label/drug-label-0006-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/b25dad4aaef9c88f0e827394a34fbbd1ce7d71422fa46b5d1e123befad498c1d/drug-label-0006-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:45:17

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 a high fever (over 101°F). cough tends to recur or is accompanied by a 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 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. Do not use if imprinted tamper-evident bottle band is broken or missing. The inner packaged bottle is child-resistant. 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 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 a high fever (over 101°F). cough tends to recur or is accompanied by a 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 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. Do not use if imprinted tamper-evident bottle band is broken or missing. The inner packaged bottle is child-resistant. 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.