COLD

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)

Brand name
COLD
Generic name
ACONITUM NAPELLUS, ALLIUM CEPA, GELSEMIUM SEMP., ZINCUM GLUCONICUM
Manufacturer
Hyland's Inc.
Product type
HUMAN OTC DRUG
SPL set ID
120c1c96-dd70-4d54-e054-00144ff8d46c
SPL ID
2b382a01-d3ae-775d-e063-6394a90a6916
Version
8
Effective date
2025-01-08
Source export date
2026-09-28
Source partition
11
Source file
https://download.open.fda.gov/drug/label/drug-label-0011-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/aa96b5a2be6b394393acd0090f6948bdf99e0e8e00666f81608929c8fa83db77/drug-label-0011-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 06:15:58
Harmonized routes table
Harmonized routes
ORAL

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 As with any drug, ask a doctor before use if pregnant or breast-feeding. Do not use more than directed. Consult a physician if: ■ symptoms persist for more than 7 days or worsen. ■ inflammation, fever (over 101°F) or infection is present or develops. ■ cough tends to recur or is accompanied by a fever (over 101°F), rash or persistent headache. Keep this and all medications out of the reach of children. 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 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 fever (over 101°F), headache, nausea and vomiting may be serious. Consult a doctor promptly. In case of emergency or accidental overdose, 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.