Daytime Cold and Flu Maximum Strength

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 Cold and Flu Maximum Strength
Generic name
ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL
Manufacturer
Shield Pharmaceuticals Corp
Product type
HUMAN OTC DRUG
SPL set ID
67849e09-2056-4013-98b1-d003ed3250a2
SPL ID
5a606ad0-f8fc-5a81-e063-6294a90ac586
Version
2
Effective date
2026-08-31
Source export date
2026-10-12
Source partition
14
Source file
https://download.open.fda.gov/drug/label/drug-label-0014-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/acb9b4700b9af1bdda1c389c7b35bfe38fd6d1a62aa48d17832812be4029b84f/drug-label-0014-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 03:13:45
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 you take more than 4000 mg of acetaminophen in 24 hours with other drugs containing acetaminophen 3 or more alcoholic drinks daily while using this product Allergy alert: Acetaminophen may cause severe skin or severe allergic reactions. Symptoms may include: skin reddening blisters rash hives facial swelling asthma (wheezing) shock. If a skin or general allergic 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 is 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.