Daytime Non-Drowsy COLD/FLU

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
Daytime Non-Drowsy COLD/FLU
Generic name
ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE
Manufacturer
Salado Sales, Inc.
Product type
HUMAN OTC DRUG
SPL set ID
e181b371-78c7-4163-865d-acc064be33ca
SPL ID
49c1c962-2dba-479b-b98a-a70e9d7dd68b
Version
5
Effective date
2023-12-29
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 06:14:50
Harmonized routes table
Harmonized routes
ORAL

Warnings cross-check#

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Warnings sections page 1 of 1 · 1 matching rows.

warnings

Warnings Liver Warning: The product contains acetaminophen. Severe liver damage may occur if ■ adult takes more than 4doses (30 mL each) in 24 hours, which is the maximum daily amount for this product ■ child takes more than 4 doses (15 mL each) in 24 hours, which is the maximum daily amount for this product ■ taken with other drugs containing acetaminophen ■ adult has 3 or more alcoholic drinks every day while using the product Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include: • skin reddening • blisters • rash. If a skin reaction occurs, stop use and seek medical help right away Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Reported adverse events (FAERS/openFDA)#

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