Daytime Severe Cold and 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 Severe Cold and Flu
Generic name
ACETAMINOPHEN,DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL
Manufacturer
Grocery Outlet, Inc.
Product type
HUMAN OTC DRUG
SPL set ID
4db0470b-1bf0-9137-e063-6394a90a1d54
SPL ID
4db066d4-ddbb-ddce-e063-6394a90ac5f8
Version
1
Effective date
2026-03-23
Source export date
2026-08-08
Source partition
2
Source file
https://download.open.fda.gov/drug/label/drug-label-0002-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-08-08/c371bcf53af83126908f941c4bb6f83aeaa6e2ef3749f9f7be6c7a3681e3b333/drug-label-0002-of-0014.json.zip
Source manifest SHA-256
b39f3b00ad50d2e1b32aaf429248c6081e8799b35bce715b4fccb8cfa1ac4546
Import run
20260810T161303Z
Imported at
2026-08-10 16:22:34
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 Liver warning: This product contains acetaminophen. Severe liver damage may occur if adult takes more than 4 doses (30 mL each) in 24 hrs, which is the maximum daily amount for this product child takes more than 4 doses (15 mL each) in 24 hrs, 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 this 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.